{"change_dates":[],"dossier":{"amendments":[{"authors":"Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-9","location":[["Proposal for a regulation","Recital 2"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(2) This Regulation aims to ensure the","functioning of the internal market as","regards medical devices, taking as a base a","high level of protection of health for health","professionals, patients, users and","operators. At the same time, this","Regulation sets high standards of quality","and safety for devices to meet common","safety concerns as regards those products.","Both objectives are being pursued","simultaneously and are inseparably linked","whilst one not being secondary to the","other. As regards Article 114 of the Treaty","on the Functioning of the European Union,","this Regulation harmonises the rules for the","placing on the market and putting into","service of in vitro diagnostic medical","devices and their accessories on the Union","market which may then benefit from the","principle of free movement of goods. As","regards Article 168(4)(c) of the Treaty on","the Functioning of the European Union,","this Regulation sets high standards of","quality and safety for those devices by","ensuring, among other things, that data","generated in clinical performance studies is","reliable and robust and that the safety of","subjects participating in clinical","performance studies is protected."],"old":["(2) This Regulation aims to ensure the","functioning of the internal market as","regards in vitro diagnostic medical devices,","taking as a base a high level of protection","of health. At the same time, this Regulation","sets high standards of quality and safety for","devices to meet common safety concerns","as regards those products. Both objectives","are being pursued simultaneously and are","inseparably linked whilst one not being","secondary to the other. As regards Article","114 of the Treaty on the Functioning of the","European Union, this Regulation","harmonises the rules for the placing on the","market and putting into service of in vitro","diagnostic medical devices and their","accessories on the Union market which","may then benefit from the principle of free","movement of goods. As regards Article","168(4)(c) of the Treaty on the Functioning","of the European Union, this Regulation sets","high standards of quality and safety for","those devices by ensuring, among other","things, that data generated in clinical","performance studies is reliable and robust","and that the safety of subjects participating","in clinical performance studies is protected."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"9","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-10","location":[["Proposal for a regulation","Recital 3"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(3) Key elements of the existing regulatory","approach, such as the supervision of","notified bodies, conformity assessment","procedures, clinical investigations and","clinical evaluation, vigilance and market","surveillance should be significantly","reinforced, whilst provisions ensuring","transparency and traceability regarding","devices should be introduced, to improve","health and safety for health professionals,","patients, users and operators, particularly","in the waste disposal chain."],"old":["(3) Key elements of the existing regulatory","approach, such as the supervision of","notified bodies, risk classification,","conformity assessment procedures, clinical","evidence, vigilance and market","surveillance should be significantly","reinforced, whilst provisions ensuring","transparency and traceability regarding in","vitro diagnostic medical devices should be","introduced to improve health and safety."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"10","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-11","location":[[" Proposal for a regulation","Recital 13 a (new)"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(13a) The Directive of the European","Parliament and of the Council on the","minimum health and safety requirements","regarding the exposure of workers to the","risks arising from physical agents","(electromagnetic fields) (XXth individual","Directive within the meaning of","Article 16(1) of Directive 89/391/EEC)1","should be the reference text for ensuring","that people working in the vicinity of","magnetic resonance imaging equipment","when it is functioning are properly","protected.","______________","1","COM(2011)0348."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"11","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-12","location":[["Proposal for a regulation","Recital 27"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchasing and waste disposal","policies and hospitals\u2019 management of","stock."],"old":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"12","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-13","location":[["Proposal for a regulation","Recital 28"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(28) Transparency and better information","are essential to empower patients,","healthcare professionals and all others","concerned, and to enable them to make","informed decisions, to provide a sound","basis for regulatory decision-making and to","build confidence in the regulatory system."],"old":["(28) Transparency and better information","are essential to empower patients and","healthcare professionals and to enable them","to make informed decisions, to provide a","sound basis for regulatory decision-making","and to build confidence in the regulatory","system."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"13","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-14","location":[[" Proposal for a regulation","Recital 29"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(29) One key aspect is the creation of a","central database that should integrate","different electronic systems, with the UDI","as an integral part of it, to collate and","process information regarding in vitro","diagnostic medical devices on the market","and the relevant economic operators,","certificates, interventional clinical","performance studies and other clinical","performance studies involving risks for the","subjects of the studies, vigilance and","market surveillance. The objectives of the","database are to enhance overall","transparency, to streamline and facilitate","the flow of information between economic","operators, notified bodies or sponsors and","Member States as well as between Member","States among themselves and with the","Commission, to avoid multiple reporting","requirements and to enhance the","coordination between Member States. The","database will also facilitate the","traceability of medical equipment donated","or exported to countries outside the EU.","Within an internal market, this can be","ensured effectively only at Union level and","the Commission should therefore further","develop and manage the European","databank on medical devices (Eudamed)","set up by Commission Decision","2010/227/EU of 19 April 2010 on the","European Databank for Medical Devices."],"old":["(29) One key aspect is the creation of a","central database that should integrate","different electronic systems, with the UDI","as an integral part of it, to collate and","process information regarding in vitro","diagnostic medical devices on the market","and the relevant economic operators,","certificates, interventional clinical","performance studies and other clinical","performance studies involving risks for the","subjects of the studies, vigilance and","market surveillance. The objectives of the","database are to enhance overall","transparency, to streamline and facilitate","the flow of information between economic","operators, notified bodies or sponsors and","Member States as well as between Member","States among themselves and with the","Commission, to avoid multiple reporting","requirements and to enhance the","coordination between Member States.","Within an internal market, this can be","ensured effectively only at Union level and","the Commission should therefore further","develop and manage the European","databank on medical devices (Eudamed) by","further developing the databank set up by","Commission Decision 2010/227/EU of 19","April 2010 on the European Databank for","Medical Devices."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"14","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-15","location":[["Proposal for a regulation","Recital 48"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(48) In order to better protect health and","safety regarding devices on the market, the","vigilance system for in vitro diagnostic","medical devices should be made more","effective by creating a central portal at","Union level for reporting serious incidents","and field safety corrective actions within","and outside the EU."],"old":["(48) In order to better protect health and","safety regarding devices on the market, the","vigilance system for in vitro diagnostic","medical devices should be made more","effective by creating a central portal at","Union level for reporting serious incidents","and field safety corrective actions."],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"15","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Philippe Boulland","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-16","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 55"]],"meps":[105624],"meta":{"created":"2019-07-03T05:22:40"},"new":["(55) \u2018field safety notice\u2019 means the","communication sent by the manufacturer to","users, waste disposal operators or","customers in relation to a field safety","corrective action;"],"old":["(55) \u2018field safety notice\u2019 means the","communication sent by the manufacturer to","users or customers in relation to a field","safety corrective action;"],"orig_lang":"fr","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"16","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-17","location":[["Proposal for a regulation","Article 39 \u2013 paragraph 4 \u2013 introductory part"]],"meps":[28324],"meta":{"created":"2019-07-03T05:22:41"},"new":["4. In the light of technical progress and any","information which becomes available in","the course of the vigilance and market","surveillance activities described in Articles","59 to 73, the Commission, having","consulted relevant stakeholders, including","healthcare professionals\u2019 organisations","and manufacturers\u2019 associations, shall be","empowered to adopt delegated acts in","accordance with Article 85 as regards the","following:"],"old":["4. In the light of technical progress and any","information which becomes available in","the course of the vigilance and market","surveillance activities described in Articles","59 to 73, the Commission shall be","","empowered to adopt delegated acts in","accordance with Article 85 as regards the","following:"],"orig_lang":"cs","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"17","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-18","location":[[" Proposal for a regulation","Article 42 \u2013 paragraph 6 a (new)"]],"meps":[28324],"meta":{"created":"2019-07-03T05:22:41"},"new":["6a. Throughout the scrutiny process, the","views of relevant stakeholders, including","patient or healthcare professionals\u2019","organisations and manufacturers\u2019","associations, shall be taken into account."],"orig_lang":"cs","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"18","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-19","location":[[" Proposal for a regulation","Article 61 \u2013 paragraph 1 \u2013 subparagraph 1"]],"meps":[28324],"meta":{"created":"2019-07-03T05:22:41"},"new":["Member States shall take the necessary","steps to ensure that any information","regarding a serious incident that has","occurred within their territory or a field","safety corrective action that has been or is","to be undertaken within their territory, and","that is brought to their knowledge in","accordance with Article 59 is, at national","level, evaluated centrally by their","competent authority, if possible together","with the manufacturer. The competent","authority shall take into account the views","of all relevant stakeholders, including","patients, healthcare professionals\u2019","organisations and manufacturers\u2019","associations."],"old":["Member States shall take the necessary","steps to ensure that any information","regarding a serious incident that has","occurred within their territory or a field","safety corrective action that has been or is","to be undertaken within their territory, and","that is brought to their knowledge in","accordance with Article 59 is, at national","level, evaluated centrally by their","competent authority, if possible together","with the manufacturer.",""],"orig_lang":"cs","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"19","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["EMPL"],"date":"2013-04-26T00:00:00","id":"PE510.535-20","location":[["Proposal for a regulation","Annex 1 \u2013 part III \u2013 point 17 \u2013 point 17.3 \u2013 point 17.3.2 \u2013 point i a (new)"]],"meps":[28324],"meta":{"created":"2019-07-03T05:22:41"},"new":["(ia) The instructions for use shall be","comprehensible to the layman and","reviewed by the representatives of relevant","stakeholders, including patients,","healthcare professionals\u2019 organisations","and manufacturers\u2019 associations."],"orig_lang":"cs","peid":"PE510.535v01-00","reference":"2012/0267(COD)","seq":"20","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.535+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Fran\u00e7oise Grosset\u00eate","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-75","location":[["Proposal for a regulation","Recital 5"]],"meps":[2025],"meta":{"created":"2019-07-03T05:26:37"},"new":["(5) There are specific features of in vitro","diagnostic medical devices, in particular in","terms of risk classification, conformity","assessment procedures and clinical","evidence, and of the in vitro diagnostic","medical device sector which require the","adoption of a specific legislation, distinct","from the legislation on other medical","devices, whereas the horizontal aspects","common to both sectors should be aligned","without compromising the need for","innovation in the Union."],"old":["(5) There are specific features of in vitro","diagnostic medical devices, in particular in","terms of risk classification, conformity","assessment procedures and clinical","evidence, and of the in vitro diagnostic","medical device sector which require the","adoption of a specific legislation, distinct","from the legislation on other medical","devices, whereas the horizontal aspects","common to both sectors should be aligned."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-76","location":[["Proposal for a regulation","Recital 7 a (new)"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:37"},"new":["(7a) In situations in which a product is","not conceived by its manufacturer to be","used for medical purposes, its certification","as an in vitro diagnostic medical device","cannot be required; likewise a product","cannot be an accessory to a specific in","vitro diagnostic medical device if it is not","specifically conceived by its manufacturer","to enable or assist the intended purpose of","the in vitro diagnostic medical device."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-77","justification":" Necessary to guarantee uniform implementation of the regulation in different Member States","location":[[" Proposal for a regulation","Recital 8"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:37"},"new":["(8) It should be the responsibility of the","Commission to decide on a case-by-case","basis whether or not a product falls within","the scope of this Regulation. If necessary,","the Commission may decide, on a case-by-","case basis, whether or not a product falls","within the definition of an in vitro","diagnostic medical device or of an","accessory to an in vitro diagnostic medical","device."],"old":["(8) It should be the responsibility of the","Member States to decide on a case-by-case","basis whether or not a product falls within","the scope of this Regulation. If necessary,","the Commission may decide, on a case-by-","case basis, whether or not a product falls","within the definition of an in vitro","diagnostic medical device or of an","accessory to an in vitro diagnostic medical","device."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-78","location":[[" Proposal for a regulation","Recital 8"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:37"},"new":["(8) In order to ensure consistent","classification across all Member States, it","should be the responsibility of the","Commission to decide on a case-by-case","basis whether or not a product or groups of","products fall within the scope of this","Regulation and within the definition of an","in vitro diagnostic medical device or of an","accessory to an in vitro diagnostic medical","device."],"old":["(8) It should be the responsibility of the","Member States to decide on a case-by-case","basis whether or not a product falls within","the scope of this Regulation. If necessary,","the Commission may decide, on a case-by-","case basis, whether or not a product falls","within the definition of an in vitro","diagnostic medical device or of an","accessory to an in vitro diagnostic medical","device."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-79","location":[["Proposal for a regulation","Recital 8 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:37"},"new":["(8a) A multidisciplinary advisory","committee of experts and representatives","of stakeholder and civil society","organisations should be set up in","accordance with the conditions and","modalities defined in Article 78a of","Regulation (EU) [Ref. of future","Regulation on medical devices] in order to","provide scientific advice to the","Commission, the Medical Device","Coordination Group (MDCG) and","Member States on issues of in vitro","diagnostic medical technology,","classification and other aspects of","implementation of this Regulation as","necessary."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-80","justification":" The words health institution have been excised \u2013 since health institutions will be exempt from\n the Regulation, then the target of this recital is actually the commercial laboratories which\n will not be exempt.","location":[["Proposal for a regulation","Recital 9"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:37"},"new":["(9) To ensure the highest level of health","protection, the rules governing in vitro","diagnostic medical devices manufactured","and used only within a single site should be","clarified and strengthened."],"old":["(9) To ensure the highest level of health","protection, the rules governing in vitro","diagnostic medical devices manufactured","and used, including measurement and","delivery of results, only within a single","health institution should be clarified and","strengthened."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-81","location":[[" Proposal for a regulation","Recital 9 a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:37"},"new":["(9a) Having regard to the principle of","subsidiarity, devices which are produced","within health institution laboratories for","use in that environment and are not","subject to commercial transactions are not","covered by this Regulation."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Esther de Lange","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-82","location":[[" Proposal for a regulation","Recital 9 a (new)"]],"meps":[38398],"meta":{"created":"2019-07-03T05:26:37"},"new":["(9a) It is of the highest importance that","patients receive clear information in cases","of serious incidents with medical devices.","Therefore, Member States should not give","any conflicting advice to their citizens on","what action to take in cases of serious","incidents, in order to prevent unequal","information for patients in different","Member States, which can lead to","confusion of patients."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor, Linda McAvan, Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-83","justification":"The proposal removes the possibility of health institutions producing or modifying class D\ndevices. There are patient needs for which there are no commercially available IVD Devices,\nsuch as the diagnosis of very rare diseases, or the identification of emerging pathogens.\nHealth institutions play a vital role in protecting public health, by manufacturing these\ndevices in-house. These amendments seek to maintain this public health function whilst\nensuring patient safety is paramount.","location":[["Proposal for a regulation","Recital 9 a (new)"]],"meps":[112620,2327,96944],"meta":{"created":"2019-07-03T05:26:38"},"new":["(9a) In the case of urgent or unmet","medical needs for patients, such as","emerging pathogens and rare diseases,","single health institutions should have the","possibility to manufacture, modify and","use devices in-house and therefore","address, within a non-commercial and","flexible framework, specific needs which","can not be met by an available CE-","marked device."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-84","location":[["Proposal for a regulation","Recital 9 b (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:38"},"new":["(9b) However, devices which are","manufactured within non-health-","institution laboratories and put into","service without being placed onto the","market are subject to this Regulation."],"old":[""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-85","location":[[" Proposal for a regulation","Recital 27"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:38"},"new":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals, pharmacies and","in wholesale. The UDI system should be","compatible with other systems which are","already on the market."],"old":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals."],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-86","justification":"It is likely an electronic medicine authentication system will be put in place pursuant to\nFalsified Medicines Directive. It is important that the systems for in vitro diagnostic medical\ndevices and medicines are compatible. Otherwise this will bring a significant and possible\nunmanageable burden for the agents of the supply chain working with both kinds of products","location":[[" Proposal for a regulation","Recital 27"]],"meps":[1927,113487,28161,21818,96914,96664,28221,39916,4282,28178],"meta":{"created":"2019-07-03T05:26:38"},"new":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals, wholesalers and","pharmacists and be compatible with other","authentication systems already in place in","those settings."],"old":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-87","location":[["Proposal for a regulation","Recital 28"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(28) Transparency and adequate access to","information, appropriately presented for","the intended user, are essential to","empower patients and healthcare","professionals and to enable them to make","informed decisions, to provide a sound","basis for regulatory decision-making and to","build confidence in the regulatory system."],"old":["(28) Transparency and better information","are essential to empower patients and","healthcare professionals and to enable them","to make informed decisions, to provide a","sound basis for regulatory decision-making","and to build confidence in the regulatory","system."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-88","location":[[" Proposal for a regulation","Recital 29"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(29) One key aspect is the creation of a","central database that should integrate","different electronic systems, with the UDI","as an integral part of it, to collate and","process information regarding in vitro","diagnostic medical devices on the market","and the relevant economic operators,","marketing authorisations, certificates,","interventional clinical performance studies","and other clinical performance studies","involving risks for the subjects of the","studies, vigilance and market surveillance.","The objectives of the database are to","enhance overall transparency, via better","access to information for the public and","healthcare professionals, to streamline and","facilitate the flow of information between","economic operators, the Agency, notified","bodies or sponsors and Member States as","well as between Member States among","themselves and with the Commission, to","avoid multiple reporting requirements and","to enhance the coordination between","Member States. Within an internal market,","this can be ensured effectively only at","Union level and the Commission should","therefore further develop and manage the","European databank on medical devices","(Eudamed) by further developing the","databank set up by Commission Decision","2010/227/EU of 19 April 2010 on the","European Databank for Medical Devices."],"old":["(29) One key aspect is the creation of a","central database that should integrate","different electronic systems, with the UDI","as an integral part of it, to collate and","process information regarding in vitro","diagnostic medical devices on the market","and the relevant economic operators,","certificates, interventional clinical","performance studies and other clinical","performance studies involving risks for the","subjects of the studies, vigilance and","market surveillance. The objectives of the","database are to enhance overall","transparency, to streamline and facilitate","the flow of information between economic","operators, notified bodies or sponsors and","Member States as well as between Member","States among themselves and with the","Commission, to avoid multiple reporting","requirements and to enhance the","coordination between Member States.","Within an internal market, this can be","ensured effectively only at Union level and","the Commission should therefore further","develop and manage the European","databank on medical devices (Eudamed) by","further developing the databank set up by","Commission Decision 2010/227/EU of 19","April 2010 on the European Databank for","Medical Devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-89","justification":"Healthcare professionals and the public will benefit from an overview of vigilance and market\nsurveillance information. As this information will require sensitive handling, the MDCG is the\nappropriate forum for providing this information for the European Databank","location":[["Proposal for a regulation","Recital 30"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:38"},"new":["(30) Eudamed\u2019s electronic systems","regarding devices on the market, the","relevant economic operators and","certificates should enable the public to be","adequately informed about devices on the","Union market. The electronic system on","clinical performance studies should serve","as tool for the cooperation between","Member States and for enabling sponsors","to submit, on a voluntary basis, a single","application for several Member States and,","in this case, to report serious adverse","events. The electronic system on vigilance","should enable manufacturers to report","serious incidents and other reportable","events and to support the coordination of","their assessment by national competent","authorities. The electronic system","regarding market surveillance should be a","tool for the exchange of information","between competent authorities. A regular","overview of vigilance and market","surveillance information should be made","available to healthcare professionals and","the public"],"old":["(30) Eudamed\u2019s electronic systems","regarding devices on the market, the","relevant economic operators and","certificates should enable the public to be","adequately informed about devices on the","Union market. The electronic system on","clinical performance studies should serve","as tool for the cooperation between","Member States and for enabling sponsors","to submit, on a voluntary basis, a single","application for several Member States and,","in this case, to report serious adverse","events. The electronic system on vigilance","should enable manufacturers to report","serious incidents and other reportable","events and to support the coordination of","their assessment by national competent","authorities. The electronic system","regarding market surveillance should be a","tool for the exchange of information","between competent authorities."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-90","location":[[" Proposal for a regulation","Recital 30"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(30) Eudamed\u2019s electronic systems","regarding devices on the market, the","relevant economic operators and","certificates should enable the public and","healthcare professionals to be adequately","informed about devices on the Union","market. Adequate levels of access for the","public and healthcare professionals to","those parts of Eudamed\u2019s electronic","systems which provide key information on","in vitro diagnostic medical devices that","may pose a risk to public health and","safety is essential. Where such access is","limited, it should be possible, upon a","reasoned request, to disclose existing","information for in vitro diagnostic","medical devices, unless the limitation of","access is justified on grounds of","confidentiality. The electronic system on","clinical performance studies should serve","as tool for the cooperation between","Member States and for enabling sponsors","to submit, on a voluntary basis, a single","application for several Member States and,","in this case, to report serious adverse","events. The electronic system on vigilance","should enable manufacturers to report","serious incidents and other reportable","events and to support the coordination of","their assessment by national competent","authorities. The electronic system","regarding market surveillance should be a","tool for the exchange of information","between competent authorities."],"old":["(30) Eudamed\u2019s electronic systems","regarding devices on the market, the","relevant economic operators and","certificates should enable the public to be","adequately informed about devices on the","Union market. The electronic system on","clinical performance studies should serve","as tool for the cooperation between","Member States and for enabling sponsors","to submit, on a voluntary basis, a single","application for several Member States and,","in this case, to report serious adverse","events. The electronic system on vigilance","should enable manufacturers to report","serious incidents and other reportable","events and to support the coordination of","their assessment by national competent","authorities. The electronic system","regarding market surveillance should be a","tool for the exchange of information","between competent authorities."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-91","justification":"Makes the recital consistent with Article 24.","location":[["Proposal for a regulation","Recital 32"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:38"},"new":["(32) For Class C and Class D in vitro","diagnostic medical devices, manufacturers","should summarise the main safety and","performance aspects of the device and the","outcome of the clinical evaluation in a","document that should be publicly available."],"old":["(32) For high-risk in vitro diagnostic","medical devices, manufacturers should","summarise the main safety and","performance aspects of the device and the","outcome of the clinical evaluation in a","document that should be publicly available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"91","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-92","location":[["Proposal for a regulation","Recital 32"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(32) For high-risk in vitro diagnostic","medical devices, manufacturers should","provide the national authority or the","Agency, as relevant, involved in the","marketing authorisation procedure, with a","full report on the safety and clinical","performance aspects of that device. A","summary of that report should be publicly","available via Eudamed."],"old":["(32) For high-risk in vitro diagnostic","medical devices, manufacturers should","summarise the main safety and","performance aspects of the device and the","outcome of the clinical evaluation in a","document that should be publicly","available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"92","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-93","location":[["Proposal for a regulation","Recital 35"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["deleted"],"old":["(35) For high risk in vitro diagnostic","medical devices, authorities should be","informed at an early stage about devices","which are subject to conformity","assessment and be given the right, on","scientifically valid grounds, to scrutinise","the preliminary assessment conducted by","notified bodies, in particular regarding","devices for which no common technical","specifications exist, devices which are","novel or for which a novel technology is","being used, devices belonging to a","category of devices with increased serious","incident rates, or devices for which","significant discrepancies in the","conformity assessments by different","notified bodies have been identified in","respect of substantially similar devices.","The process foreseen in this Regulation","does not prevent a manufacturer from","informing voluntarily a competent","authority of his intention to file an","application for conformity assessment for","a high risk in vitro diagnostic medical","device before submitting the application to","the notified body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"93","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-94","justification":"Necessary to clarify which authorities are referred to in the recital.","location":[[" Proposal for a regulation","Recital 35"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:38"},"new":["(35) For high risk in vitro diagnostic","medical devices, relevant authorities at","national and Union level should be","informed at an early stage about devices","which are subject to conformity assessment","and be given the right, on scientifically","valid grounds, to scrutinise the preliminary","assessment conducted by notified bodies,","in particular regarding devices for which","no common technical specifications exist,","devices which are novel or for which a","novel technology is being used, devices","belonging to a category of devices with","increased serious incident rates, or devices","for which significant discrepancies in the","conformity assessments by different","notified bodies have been identified in","respect of substantially similar devices.","The process foreseen in this Regulation","does not prevent a manufacturer from","informing voluntarily a competent","authority of his intention to file an","application for conformity assessment for a","high risk in vitro diagnostic medical device","before submitting the application to the","notified body."],"old":["(35) For high risk in vitro diagnostic","medical devices, authorities should be","informed at an early stage about devices","which are subject to conformity assessment","and be given the right, on scientifically","","valid grounds, to scrutinise the preliminary","assessment conducted by notified bodies,","in particular regarding devices for which","no common technical specifications exist,","devices which are novel or for which a","novel technology is being used, devices","belonging to a category of devices with","increased serious incident rates, or devices","for which significant discrepancies in the","conformity assessments by different","notified bodies have been identified in","respect of substantially similar devices.","The process foreseen in this Regulation","does not prevent a manufacturer from","informing voluntarily a competent","authority of his intention to file an","application for conformity assessment for a","high risk in vitro diagnostic medical device","before submitting the application to the","notified body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-95","location":[["Proposal for a regulation","Recital 35"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:38"},"new":["(35) For high risk in vitro diagnostic","medical devices, authorities should be","informed at an early stage about devices","which are subject to conformity assessment","and be given the right, on scientifically","valid grounds, to scrutinise the preliminary","assessment conducted by notified bodies,","in particular regarding devices for which","no common technical specifications exist,","devices which are novel or for which a","novel technology is being used, devices","belonging to a category of devices with","increased serious incident rates, or devices","for which significant discrepancies in the","conformity assessments by different","notified bodies have been identified in","respect of substantially similar devices.","The process foreseen in this Regulation","does not prevent a manufacturer from","informing voluntarily a competent","authority of his intention to file an","application for conformity assessment for a","high risk in vitro diagnostic medical device","before submitting the application to the","notified body. For high-risk in vitro","diagnostic medical devices of class D a","market authorization procedure is","created."],"old":["(35) For high risk in vitro diagnostic","medical devices, authorities should be","informed at an early stage about devices","which are subject to conformity assessment","and be given the right, on scientifically","valid grounds, to scrutinise the preliminary","assessment conducted by notified bodies,","in particular regarding devices for which","","no common technical specifications exist,","devices which are novel or for which a","novel technology is being used, devices","belonging to a category of devices with","increased serious incident rates, or devices","for which significant discrepancies in the","conformity assessments by different","notified bodies have been identified in","respect of substantially similar devices.","The process foreseen in this Regulation","does not prevent a manufacturer from","informing voluntarily a competent","authority of his intention to file an","application for conformity assessment for a","high risk in vitro diagnostic medical device","before submitting the application to the","notified body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-96","location":[[" Proposal for a regulation","Recital 35 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(35a) The conformity assessment","procedure should not be applicable for","class D in vitro diagnostic medical","devices. A swift centralized marketing","authorization procedure should be","introduced for innovative class D devices.","A swift decentralized marketing","authorization procedure should be","introduced for all other class D devices,","with the possibility for manufacturers of","those types of devices to rather apply to","the centralized marketing authorization","procedure."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-97","location":[["Proposal for a regulation","Recital 38"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:38"},"new":["(38) The conformity assessment procedure","for class A in vitro diagnostic medical","devices should be carried out, as a general","rule, under the sole responsibility of the","manufacturers, since such devices pose a","low risk to patients. For in vitro diagnostic","medical devices in classes B and C, the","involvement of a notified body should be","compulsory to the appropriate degree. For","devices of class D a marketing","authorization procedure should be","compulsory."],"old":["(38) The conformity assessment procedure","for class A in vitro diagnostic medical","devices should be carried out, as a general","rule, under the sole responsibility of the","manufacturers, since such devices pose a","low risk to patients. For in vitro diagnostic","medical devices in classes B, C and D, the","involvement of a notified body should be","compulsory to the appropriate degree."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"97","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-98","location":[["Proposal for a regulation","Recital 38"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:38"},"new":["(38) The conformity assessment procedure","for class A in vitro diagnostic medical","devices should be carried out, as a general","rule, under the sole responsibility of the","manufacturers, since such devices pose a","low risk to patients. For in vitro diagnostic","medical devices in classes B and C the","involvement of a notified body should be","compulsory to the appropriate degree. For","in vitro diagnostic medical devices in class","D, the involvement of the Agency or of the","Member States should be compulsory."],"old":["(38) The conformity assessment procedure","for class A in vitro diagnostic medical","devices should be carried out, as a general","rule, under the sole responsibility of the","manufacturers, since such devices pose a","low risk to patients. For in vitro diagnostic","medical devices in classes B, C and D, the","involvement of a notified body should be","compulsory to the appropriate degree."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-99","justification":" This recital aims to protect whistleblowers.","location":[[" Proposal for a regulation","Recital 42 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:38"},"new":["(42a) To ensure general market safety,","any natural or legal person has the right","to make public or distribute in good faith","information on a fact, an item of data or","an action, as soon as a lack of knowledge","of this fact, this item of data or this action","appears to present a danger to health or","the environment."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-100","location":[[" Proposal for a regulation","Recital 44 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(44a) An interventional clinical","performance studies or any other clinical","performance study should only start after","being granted a positive evaluation by an","independent ethics committee. Member","States should take the necessary measures","to establish Ethics Committees where","such committees do not exist."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-101","location":[["Proposal for a regulation","Recital 45"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(45) Sponsors of interventional clinical","performance studies and other clinical","performance studies involving risks for the","subjects to be conducted in more than one","Member State should be given the","possibility to submit a single application in","order to reduce administrative burden. In","order to allow for resource-sharing and to","ensure consistency regarding the","assessment of the health and safety related","aspects of the device for performance","evaluation and of the scientific design of","the clinical performance study to be","conducted in several Member Stats, such","single application should facilitate the","coordination between the Member States","under the direction of a coordinating","Member State. Each Member State should","retain the ultimate responsibility for","deciding whether the clinical performance","study may be conducted on its territory."],"old":["(45) Sponsors of interventional clinical","performance studies and other clinical","performance studies involving risks for the","subjects to be conducted in more than one","Member State should be given the","possibility to submit a single application in","order to reduce administrative burden. In","order to allow for resource-sharing and to","ensure consistency regarding the","assessment of the health and safety related","aspects of the device for performance","evaluation and of the scientific design of","the clinical performance study to be","conducted in several Member Stats, such","single application should facilitate the","coordination between the Member States","under the direction of a coordinating","Member State. The coordinated","assessment should not include the","assessment of intrinsically national, local","and ethical aspects of a clinical","performance study, including informed","consent. Each Member State should retain","the ultimate responsibility for deciding","whether the clinical performance study","may be conducted on its territory."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-102","justification":" The Vigilance procedures in Chapter VII will only function correctly if healthcare\n professionals feel able to report incidents without fear of retribution. In some circumstances,\n anonymous whistle-blower protection may be needed in order to ensure full and frank\n incident reporting.","location":[["Proposal for a regulation","Recital 49"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:39"},"new":["(49) Healthcare professionals and patients","should be empowered to report suspected","serious incidents at national level, using","harmonised formats, and guaranteeing","anonymity, where appropriate. The","national competent authorities should","inform manufacturers and share the","information with their peers when they","confirm that a serious incident has","occurred in order to minimise recurrence of","those incidents."],"old":["(49) Healthcare professionals and patients","should be empowered to report suspected","serious incidents at national level using","harmonised formats. The national","competent authorities should inform","manufacturers and share the information","with their peers when they confirm that a","serious incident has occurred in order to","minimise recurrence of those incidents."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-103","location":[[" Proposal for a regulation","Recital 49"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(49) Member States should take all","necessary measures to raise awareness","among healthcare professionals, users","and patients about the importance of","reporting suspected serious incidents.","Healthcare professionals and patients","should be empowered to report suspected","serious incidents at national level using","harmonised formats. In order to minimise","the recurrence of such incidents, the","national competent authorities should","inform manufacturers and report the","information via the respective electronic","system in Eudamed when they confirm","that a serious incident has occurred in order","to minimise recurrence of those incidents."],"old":["(49) Healthcare professionals and patients","should be empowered to report suspected","serious incidents at national level using","harmonised formats. The national","competent authorities should inform","manufacturers and share the information","with their peers when they confirm that a","serious incident has occurred in order to","minimise recurrence of those incidents.","",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-104","location":[["Proposal for a regulation","Recital 53"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(53) The Member States shall levy fees for","the designation and monitoring of notified","bodies to ensure sustainability of the","monitoring of those bodies by Member","States and to establish a level playing field","for notified bodies. These fees should be","comparable across Member States and","should be made public."],"old":["(53) The Member States shall levy fees for","the designation and monitoring of notified","bodies to ensure sustainability of the","monitoring of those bodies by Member","States and to establish a level playing field","for notified bodies."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-105","location":[["Proposal for a regulation","Recital 54"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(54) Whilst this Regulation should not","affect the right of the Member States to","levy fees for activities at national level,","Member States should inform the","Commission and the other Member States","before they adopt the comparable level and","structure of the fees to ensure transparency."],"old":["(54) Whilst this Regulation should not","affect the right of the Member States to","levy fees for activities at national level,","Member States should inform the","Commission and the other Member States","before they adopt the level and structure of","the fees to ensure transparency."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"105","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-106","location":[[" Proposal for a regulation","Recital 54 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(54a) Member States should adopt","regulations on standard fees for notified","bodies, which should be comparable","across Member States. The Commission","should provide guidelines to facilitate the","comparability of those fees. Member","States should transmit their list of","standard fees to the Commission and","ensure that the notified bodies registered","on their territory make the lists of","standard fees for their conformity","assessment activities publicly available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-107","location":[[" Proposal for a regulation","Recital 55"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:39"},"new":["(55) A Medical Device Coordination","Group (MDCG), composed of persons","designated by the Member States, based on","their role and expertise in the field of","medical devices and in vitro diagnostic","medical devices, should be established in","accordance with the conditions and","modalities defined in Article 78 of","Regulation (EU) [Ref. of future Regulation","on medical devices] on medical devices to","fulfil the tasks conferred on it by this","Regulation and by Regulation (EU) [Ref.","of future Regulation on medical devices]","on medical devices, to provide advice to","the Commission and to assist the","Commission and the Member States in","ensuring a harmonised implementation of","this Regulation."],"old":["(55) An expert committee, the Medical","Device Coordination Group (MDCG),","composed of persons designated by the","Member States, based on their role and","expertise in the field of medical devices","and in vitro diagnostic medical devices,","should be established in accordance with","the conditions and modalities defined in","Article 78 of Regulation (EU) [Ref. of","future Regulation on medical devices] on","medical devices to fulfil the tasks","conferred on it by this Regulation and by","Regulation (EU) [Ref. of future Regulation","on medical devices] on medical devices, to","provide advice to the Commission and to","","assist the Commission and the Member","States in ensuring a harmonised","implementation of this Regulation."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"107","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-108","location":[["Proposal for a regulation","Recital 55"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:39"},"new":["(55) An expert committee, the Medical","Device Coordination Group (MDCG),","composed of persons designated by the","Member States, based on their role and","expertise in the field of medical devices","and in vitro diagnostic medical devices,","should be established in accordance with","the conditions and modalities defined in","Article 78 of Regulation (EU) [Ref. of","future Regulation on medical devices] on","medical devices to fulfil the tasks","conferred on it by this Regulation and by","Regulation (EU) [Ref. of future Regulation","on medical devices] on medical devices, to","provide advice to the Commission and to","assist the Commission and the Member","States in ensuring a harmonised","implementation of this Regulation. Prior to","taking up their duties, members of the","MDCG shall make available a declaration","of commitment and a declaration of","interests indicating either the absence of","any interests which might be considered","prejudicial to their independence or any","direct or indirect interests which might be","prejudicial to their independence. Those","declarations shall be verified by the","Commission."],"old":["(55) An expert committee, the Medical","Device Coordination Group (MDCG),","composed of persons designated by the","Member States, based on their role and","expertise in the field of medical devices","and in vitro diagnostic medical devices,","should be established in accordance with","the conditions and modalities defined in","Article 78 of Regulation (EU) [Ref. of","future Regulation on medical devices] on","medical devices to fulfil the tasks","conferred on it by this Regulation and by","Regulation (EU) [Ref. of future Regulation","on medical devices] on medical devices, to","provide advice to the Commission and to","assist the Commission and the Member","States in ensuring a harmonised","implementation of this Regulation."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"108","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-109","justification":" The electronic system plays a vital role in this regulation and should be put in place and\n become fully effective after 12 years.","location":[[" Proposal for a regulation","Recital 65"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:39"},"new":["(65) In order to ensure a smooth transition","to the registration of in vitro diagnostic","medical devices, of relevant economic","operators and of certificates, the obligation","to submit the relevant information to the","electronic systems put in place by this","Regulation at Union level should become","fully effective 12 months after the date of","application of this Regulation. During this","transitional period, Article 10 and points","(a) and (b) of Article 12(1) of Directive","98/79/EC should remain in force.","However, economic operators and notified","bodies who register in the relevant","electronic systems provided for at Union","level should be considered in compliance","with the registration requirements adopted","by the Member States pursuant to those","provisions of the Directive to avoid","multiple registrations."],"old":["(65) In order to ensure a smooth transition","to the registration of in vitro diagnostic","medical devices, of relevant economic","operators and of certificates, the obligation","to submit the relevant information to the","electronic systems put in place by this","Regulation at Union level should become","fully effective only 18 months after the","date of application of this Regulation.","During this transitional period, Article 10","and points (a) and (b) of Article 12(1) of","Directive 98/79/EC should remain in force.","However, economic operators and notified","bodies who register in the relevant","electronic systems provided for at Union","level should be considered in compliance","with the registration requirements adopted","by the Member States pursuant to those","provisions of the Directive to avoid","multiple registrations."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"109","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-110","location":[[" Proposal for a regulation","Article 1 \u2013 paragraph 6"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:39"},"new":["6. This Regulation shall not affect national","laws which require that certain devices","may only be supplied on a medical","prescription. Direct to consumer","advertising of devices classed as","prescription only by this regulation shall","be illegal.","The following devices may only be","supplied on a medical prescription:","1) Class D devices","2) Class C devices in the following","categories:","(a). devices for genetic testing;","(b). companion diagnostics.","The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 to decide on self-testing devices","and other category C tests after","consultation with stakeholders."],"old":["6. This Regulation shall not affect national","laws which require that certain devices","may only be supplied on a medical","prescription."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Christel Schaldemose, Alda Sousa, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Mairead McGuinness, Richard Seeber, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-111","location":[["Proposal for a regulation","Article 1 \u2013 paragraph 6"]],"meps":[1927,37312,113487,21818,96914,96664,28221,39916,4282,28115,28252,28178],"meta":{"created":"2019-07-03T05:26:39"},"new":["6. This Regulation requires that certain","devices may only be supplied on a medical","prescription but shall not affect national","laws which require that certain other","devices may also only be supplied on a","medical prescription. Direct to consumer","advertising of devices classed as","prescription only by this regulation shall","be illegal.","The following devices may only be","supplied on a medical prescription:","1) Class D devices","2) Class C devices in the following","categories:","(a) devices for genetic testing;","(b) companion diagnostics.","The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 to decide on other category C","tests after consultation with stakeholders."],"old":["6. This Regulation shall not affect national","laws which require that certain devices","may only be supplied on a medical","prescription.","",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"111","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-112","justification":" The prediction and prognosis of diseases are vital functions of devices","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 1 \u2013 indent 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:39"},"new":["\u2013 diagnosis, prevention, monitoring,","prediction, prognosis, treatment or","alleviation of disease,"],"old":["\u2013 diagnosis, prevention, monitoring,","treatment or alleviation of disease,"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-113","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 3"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:39"},"new":["(3) \u2018accessory to an in vitro diagnostic","medical device\u2019 means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable the","in vitro diagnostic medical device(s) to be","used in accordance with its/their intended","purpose(s) or to specifically assist the","medical functionality of the in vitro","diagnostic medical device(s) in view of","its/their intended purpose(s);"],"old":["(3) \u2018accessory to an in vitro diagnostic","medical device\u2019 means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable or","assist the in vitro diagnostic medical","device(s) to be used in accordance with","its/their intended purpose(s);"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-114","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 4"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:39"},"new":["(4) \u2018accessory to an in vitro diagnostic","medical device\u2019 means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable the","in vitro diagnostic medical device(s) to be","used in accordance with its/their intended","purpose(s) or to specifically support the","medical applications of the device(s) in","respect of its/their intended purpose(s);"],"old":["(4) \u2018accessory to an in vitro diagnostic","medical device\u2019 means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable or","assist the in vitro diagnostic medical","device(s) to be used in accordance with","its/their intended purpose(s);"],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"114","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna","changes":{},"committee":["ENVI"],"compromise":[" Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Nora Berra, Miroslav"," Mikol\u00e1\u0161ik"],"date":"2013-05-13T00:00:00","id":"PE510.740-115","justification":" Self--testing devices have specific conformity assessment requirements, e.g. studies with users\n and instructions etc. in language of intended users, which are designed to mitigate the risks\n specific to such devices, i.e. the lack of medical/technical/scientific training of lay user. This\n specific type of risk is the same whether the test is purchased as a kit in a shop or as a service\n over the internet.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 4"]],"meps":[1927,113487,28161,21818,96914],"meta":{"created":"2019-07-03T05:26:40"},"new":["(4) \u2018device for self-testing\u2019 means any","device intended by the manufacturer to be","used by lay persons, including testing","services offered to lay persons by means","of information society services;"],"old":["(4) \u2018device for self-testing\u2019 means any","device intended by the manufacturer to be","used by lay persons;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"115","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-116","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 6"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:40"},"new":["(6) \u2018companion diagnostic\u2019 means a device","specifically intended to select patients with","a previously diagnosed condition or","predisposition as eligible for a specific","therapy;"],"old":["(6) \u2018companion diagnostic\u2019 means a device","specifically intended to select patients with","a previously diagnosed condition or","predisposition as eligible for a targeted","therapy;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"116","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-117","justification":"The current definition is too limited, e.g. it does not include companion diagnostics used to\nguide dosage decisions (e.g. pharmacogenetic tests for warfarin treatment) which may have\nan important role to play in ensuring the safety and effectiveness of a specific drug.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 6"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(6) \u2018companion diagnostic\u2019 means a device","intended to provide information that is","essential for the safe and effective use of a","corresponding therapeutic product. The","use of a companion diagnostic with a","particular therapeutic product is indicated","as desirable in the instructions for use in","the labelling of both the diagnostic device","and the corresponding therapeutic","product, as well as in the labelling of any","generic equivalents of the therapeutic","product or is the stated intended purpose","of the diagnostic device.","An IVD companion diagnostic device","could be essential for the safe and","effective use of a corresponding","therapeutic product to:","\u2013 identify patients who are most likely to","benefit from a particular therapeutic","product;","\u2013 identify patients likely to be at increased","risk for serious adverse reactions as a","result of treatment with a particular","therapeutic product;","\u2013 monitor response to treatment for the","purpose of adjusting treatment (e.g.","schedule, dose, discontinuation) to","achieve improved safety or effectiveness."],"old":["(6) \u2018companion diagnostic\u2019 means a device","specifically intended to select patients with","a previously diagnosed condition or","predisposition as eligible for a targeted","therapy;","","",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"117","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-118","justification":" The current definition of a label does not cover laboratory-developed tests. Recipients of the\n results generated by such devices should have the same access to the information contained\n on the label as do users of other IVD devices.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 10"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(10) \u2018label\u2019 means the written, printed, or","graphic information appearing either on the","device itself, or on the packaging of each","unit, or on the packaging of multiple","devices or on the manufacturer\u2019s website;"],"old":["(10) \u2018label\u2019 means the written, printed, or","graphic information appearing either on the","device itself, or on the packaging of each","unit, or on the packaging of multiple","devices;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"118","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-119","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 12 a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(12a) \u2018novel device\u2019 means:","\u2013 a device which incorporates technology","(the analyte, technology or test platform)","not previously used in diagnostics, or;","\u2013 an existing device which is being used","for a new intended purpose for the first","time;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"119","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Christel Schaldemose, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer,","changes":{},"committee":["ENVI"],"compromise":["Mairead McGuinness, Richard Seeber, Nora Berra, Miroslav Mikol\u00e1\u0161ik"],"date":"2013-05-13T00:00:00","id":"PE510.740-120","justification":"Other definition compared to Amendment 18 in the draft report","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 12 a (new)"]],"meps":[1927,37312,113487,28161,21818,96914,96664,28221,39916,4282],"meta":{"created":"2019-07-03T05:26:40"},"new":["(12a) \u2018 device for genetic testing\u2019 means","an in vitro diagnostic medical device the","purpose of which is to identify a genetic","characteristic of a person which is","inherited or acquired during prenatal","development."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"120","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach, Christofer Fjellner","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-121","justification":"It is too unclear what could fall under the category of a organisation who\u2019s primary purpose\nis \u201cthe promotion of public health\u201d since it is not defined elsewhere. So to avoid confusion\nand uncertainties it should be deleted.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 3 \u2013 point 21"]],"meps":[96664,28126],"meta":{"created":"2019-07-03T05:26:40"},"new":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients;"],"old":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"121","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-122","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 3 \u2013 point 21"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(21) \u2018health institution\u2019 means an","organisation within a Member State\u2019s","public healthcare system whose primary","purpose is the care or treatment of patients","or the promotion of public health;","commercial laboratories which provide","diagnostic services are not health","institutions."],"old":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"122","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-123","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 3 \u2013 point 21"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:40"},"new":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health, with the","exclusion of laboratories providing","commercial clinical services;"],"old":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"123","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-124","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 3 \u2013 point 22"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:40"},"new":["(22) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients and which has","the legal capacity to carry out such","activities;"],"old":["(22) \u2018health institution\u2019 means an","organisation whose primary purpose is the","","care or treatment of patients or the","promotion of public health;"],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"124","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-125","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 32"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(32) \u2018clinical performance\u2019 means the","clinical validity, and if appropriate, the","clinical utility of the device in relation to","its intended purpose;"],"old":["(32) \u2018clinical performance\u2019 means the","ability of a device to yield results that are","correlated with a particular clinical","condition or a physiological state in","accordance with the target population and","intended user;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"125","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-126","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 32 a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(32a) \u2018clinical validity\u2019 means a device\u2019s","ability to detect or predict a particular","clinical condition or physiological state in","relation to its intended purpose (e.g.","screening, diagnosis, prognosis);"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"126","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-127","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 32 b (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["(32b) \u2018clinical utility\u2019 means the","anticipated effect(s) of the clinical use of","the test result, including on health","outcomes, where the intended purpose of","a device, as stated by the manufacturer,","includes a clinical use such as selection of","a therapy (e.g. companion diagnostic);"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"127","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-128","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 38"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:41"},"new":["(38) \u2018diagnostic specificity\u2019 means the","proportion of subjects who do not have or","a specified clinical disorder whose test","results are negative or within the defined","decision limit;"],"old":["(38) \u2018diagnostic specificity\u2019 means the","ability of a device to recognize the absence","of a target marker associated with a","particular disease or condition;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"128","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-238","location":[["Proposal for a regulation","Chapter 5 \u2013 title"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:40"},"new":["Classification, marketing authorisation","and conformity assessment"],"old":["Classification and conformity assessment"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"238","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-239","location":[["Proposal for a regulation","Article 39 \u2013 paragraph 1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:40"},"new":["1. Devices shall be divided into class A, B,","C and D, taking into account their intended","purpose, novelty, complexity and inherent","risks. Classification shall be carried out in","accordance with the classification criteria","set out in Annex VII."],"old":["1. Devices shall be divided into class A, B,","C and D, taking into account their intended","purpose and inherent risks. Classification","shall be carried out in accordance with the","classification criteria set out in Annex VII."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"239","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-129","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 39"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:41"},"new":["(39) \u2018diagnostic sensitivity\u2019 means the","proportion of subjects with a well-defined","clinical disorder whose test values are","positive or exceed a defined decision limit","(i.e. a positive result and identification of","the subjects who have a disease);"],"old":["(39) \u2018diagnostic sensitivity\u2019 means the","ability of a device to identify the presence","of a target marker associated with a","particular disease or condition;",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"129","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-240","location":[["Proposal for a regulation","Chapter 5 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Chapter V Chapter III","Marketing authorisation and conformity","assessment"],"old":["Classification and conformity assessment"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"240","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-130","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 45"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:41"},"new":["(45) \u2018sponsor\u2019 means any individual,","company, institution or organisation which","takes responsibility for the initiation,","management or financing of a clinical","performance study;"],"old":["(45) \u2018sponsor\u2019 means any individual,","company, institution or organisation which","takes responsibility for the initiation and","management of a clinical performance","study;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"130","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-241","location":[[" Proposal for a regulation","Chapter 5 \u2013 section 1 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Chapter II","Classification"],"old":["Section 1 \u2013 Classification"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"241","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-131","justification":"This wording brings the text in line with ISO 14155:2011 Clinical investigation of medical\ndevices for human subjects \u2014 Good clinical practice","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 47 \u2013 indent 2 \u2013 point iii"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:41"},"new":["(iii) hospitalisation or prolongation of","patient hospitalisation,"],"old":["(iii) hospitalisation or extending the","duration of hospitalisation,"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"131","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-242","location":[[" Proposal for a regulation","Chapter 5 \u2013 section 1 a \u2013 Article 39 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Section 1a \u2013 Marketing authorisation","Article 39 a (new)","General principles regarding the","marketing authorisation","1. None of the innovative class D devices","may be placed on the market within the","Union unless a Union marketing","authorisation has been granted through","the centralised procedure referred to in","Article 39c, and in accordance with the","provisions of this Regulation.","2. None of the non-innovative class D","devices may be placed on the market of a","Member State unless a national","marketing authorisation has been granted","by the competent authority of that","Member State through the decentralised","procedure referred to in Article 39d, and","in accordance with the provisions of this","Regulation.","3. By way of derogation from paragraph","2, the manufacturer may decide to apply","for a marketing authorisation under the","centralised procedure for the devices","included in paragraph 2.","4. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 to amend the list set out in","paragraph 1, in the light of technical","progress.","5. Devices referred to in paragraphs 1 and","2, and which are already on the Union","market at the date of entry into force of","this Regulation, shall be required to have","a marketing authorisation, in accordance","with the procedures set out in this Section,","as from the expiry date of the validity of","their certificate.","6. A marketing authorisation granted","under this Section shall be valid for five","years.","The marketing authorisation may be","renewed after five years on the basis of a","re-evaluation of the risk-benefit balance","by the Agency.","7. All applications for marketing","authorisation and granted marketing","authorisations under the provisions of","Articles 39c, 39d, 39e and 39f as well as","the information referred to in Article 39b","shall be entered either by the Commission","or the Member States, as relevant, in the","electronic system referred to in Article","39b(1), without delay and at the latest 15","days after receipt.","Before commencing the review of an","application for a medical device, the","Committee for the Authorisation of","Medical Devices, as referred to in Article","41c, or the competent authority of the","relevant Member State shall verify that no","other application has been introduced for","the same medical device."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"242","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Nora Berra","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-132","justification":" The meaning of the term \u201cdurability\u201d is not entirely clear and could be subject to\n misunderstanding","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 5 \u2013 point 48"]],"meps":[1927,96947],"meta":{"created":"2019-07-03T05:26:41"},"new":["(48) \u2018device deficiency\u2019 means any","inadequacy in the identity, quality,","stability, reliability, safety or performance","of a device for performance evaluation,","including malfunction, use errors or","inadequacy in the information supplied by","the manufacturer;"],"old":["(48) \u2018device deficiency\u2019 means any","inadequacy in the identity, quality,","durability, reliability, safety or","performance of a device for performance","evaluation, including malfunction, use","errors or inadequacy in the information","supplied by the manufacturer;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"132","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-243","location":[[" Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 b (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Article 39 b (new)","Electronic system on marketing","authorisations","1. The Commission shall, in collaboration","with the Member States, set up and","manage an electronic registration system","for the applications for marketing","authorisations and granted marketing","authorisations under this Section and to","collate and process the following","information:","- the name of the manufacturer,","- the name and the risk-class of the","medical device,","- the applicable procedure,","- in the case of a decentralised procedure,","the Member State in which the","manufacturer has applied,","- the documentation accompanying the","application for a marketing authorisation,","- the assessment report for the medical","device issued during the marketing","authorisation procedure,","- the date of the marketing authorisation","approval and, where different, the date on","which the device is placed on the market,","- any information regarding the","suspension or withdrawal of the","marketing authorisation.","2. The information collated and processed","in the electronic system which relates to","the centralised procedure as referred to in","Article 39c shall be entered into the","electronic registration system by the","European Medicines Agency","The information collated and processed in","the electronic system which relates to the","decentralised procedure as referred to in","Article 39d shall be entered into the","electronic registration system by the","Member States.","3. In case where this information needs to","be updated, with regards to placing of the","device on the market, the suspension or","withdrawal of the device from the market,","the manufacturer shall immediately","inform the Agency or the national","competent authority, as relevant, who","shall immediately update the information","in the electronic system.","4. The information collated and processed","in the electronic system which relates to","applications for marketing authorisations","shall be accessible only to the Member","States, the Agency and the Commission.","The information collated and processed in","the electronic system and which relates to","granted marketing authorisations shall be","accessible to the public."],"old":["",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"243","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-133","justification":"Recitals 9 and 15 and Articles 4 and 5 reflect the desire to ensure that IVD devices developed\nand used within a single site (subject of course to the health institution exemption, see below)\nare subject to the requirements of the Regulation. However, the Regulation lacks a clear\ndefinition of such devices. Such a definition is needed in order to avoid confusion.","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 7 \u2013 point 58 a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:41"},"new":["(58a) \u2018laboratory-developed test\u2019 means a","device that is manufactured and used only","within a single site. This includes devices","which a laboratory develops de novo, or","develops or modifies from a published","source, or develops or modifies from any","other source, and devices for which a","laboratory:","\u2013 changes the intended purpose of a","device already placed on the market or put","into service;","\u2013 modifies a device already placed on the","market or put into service in such a way","that compliance with the applicable","requirements may be affected."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"133","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-244","location":[["Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 c (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Article 39 c (new)","Centralised procedure","1. A Committee for the Authorisation of","In Vitro Diagnostic Medical Devices is","hereby established in accordance with the","provisions of Article 39d. The Committee","shall be part of the European Medicines","Agency.","2. The Committee for the Authorisation of","In Vitro Diagnostic Medical Devices shall","be responsible for drawing up the opinion","of the Agency on any matter concerning","the admissibility of applications submitted","in accordance with the centralised","procedure, the granting, variation,","suspension or revocation of an","authorisation to place class D devices on","the market.","3. Each application for the devices","referred to in Article 39a (1) shall include","the particulars and documents as referred","to in Annexes VII, IX and X, as relevant.","4. The application shall be accompanied","by the fee payable to the Agency for","examining the application.","5. The Agency shall ensure that the","opinion of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices is issued within 210 days","from receipt of a valid application.","The Committee for the Authorisation of","Medical Devices shall be given at least 80","days from receipt of an application for","analysing the scientific data in the","documentation accompanying an","application for a marketing authorisation.","On the basis of a duly reasoned request,","from the Committee for the Authorisation","of In Vitro Diagnostic Medical Devices,","the Agency may extend that period.","6. The Committee may only once request","the manufacturer to submit additional","information that for scientifically valid","grounds is necessary for the assessment of","the application for marketing","authorisation. This may include a request","for samples or an on-site visit to the","manufacturer's premises. Where such a","request has been made, the period","referred to in paragraph 5 shall be","suspended until the additional","information requested has been supplied.","7. The Commission shall, in consultation","with the Agency, the Member States and","interested parties, draw up a detailed","guide concerning the form in which","applications for authorisation are to be","presented.","8. Where the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices considers it necessary in","order to complete its examination of an","application, it may require the applicant","to undergo a specific inspection of the","manufacturing site of the device","concerned. Such inspections shall be","made unannounced.","The inspection shall be carried out within","the time-limit laid down in paragraph 5 by","inspectors from the Member State holding","the appropriate qualifications. Those","inspectors may be accompanied by a","rapporteur or an expert appointed by the","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices.","9. The Agency shall forthwith inform the","applicant if the opinion of the Committee","for the Authorisation of In Vitro","Diagnostic Medical Devices is that:","(a) the application does not satisfy the","criteria for authorisation set out in this","Regulation;","(b) the documentation accompanying the","application is not in compliance with the","provisions of this Regulation or needs to","be amended or supplemented;","(c) the marketing authorisation needs to","be granted subject to certain conditions.","(d) the marketing authorisation for the","medical device concerned needs to be","refused on grounds that the device does","not comply with this Regulation.","10. Within 15 days of receipt of the","opinion referred to in paragraph 9, the","applicant may notify the Agency in","writing of his intention to request a re-","examination of the opinion. In such a","case, the applicant shall transmit to the","Agency the detailed grounds for such a","request within 60 days of receipt of the","opinion.","Within 60 days following receipt of the","grounds for the request, the Committee","for the Authorisation of In Vitro","Diagnostic Medical Devices shall re-","examine its opinion in accordance with","the conditions laid down in the fourth","subparagraph of Article 62(1) of","Regulation (EC) 726/2004. The reasons","for the conclusion reached shall be","annexed to the final opinion.","11. Within 15 days from its adoption, the","Agency shall send the final opinion of the","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices to the","Commission, the Member States and the","applicant, together with a report","describing the assessment of the device by","the Committee for the Authorisation of In","Vitro Diagnostic Medical Devices and","stating the reasons for its conclusions.","12. If an applicant withdraws an","application for a marketing authorisation","submitted to the Agency before an opinion","has been issued concerning that","application, the applicant shall","communicate its reasons for withdrawal","to the Agency. The Agency shall make","this information publicly available and","shall publish the assessment report, if","available, after deleting all information of","a commercially confidential nature.","13. Within 15 days of receipt of the","opinion referred to in paragraph 11, the","Commission shall prepare a draft of the","decision to be taken in respect of the","application.","Where the draft decision diverges from","the opinion of the Agency, the","Commission shall annex a detailed","explanation of the reasons for the","differences.","The draft decision shall be transmitted to","the Member States and the applicant.","Member States shall have 22 days to","submit their written observations on the","draft decision to the Commission.","However, if a decision has to be taken","urgently, a shorter time-limit may be set","by the Chairperson of the Committee for","the Authorisation of In Vitro Diagnostic","Medical Devices according to the degree","of urgency involved. This time-limit shall","not, otherwise than in exceptional","circumstances, be shorter than 5 days;","14. Member States may request in writing","that the draft decision referred to in","paragraph 13 be discussed by a plenary","meeting of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices, stating their reasons in","detail.","Where, in the opinion of the Commission,","a Member State's written observations","raise important new questions of a","scientific or technical nature which the","opinion delivered by the Agency has not","addressed, the Chairperson of the","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall","suspend the procedure and refer the","application back to the Agency for further","consideration.","15. The Commission shall take a final","decision within 30 days from the end of","the examination procedure referred to in","Article 84(3).","16. The refusal of a marketing","authorisation shall constitute a","prohibition on the placing on the market","of the devices referred to in Article 39a(1)","throughout the Union.","17. After a marketing authorisation has","been granted, the marketing authorisation","holder shall inform the Agency of the","dates of actual placing on the market of","the device in the Member States, taking","into account the various presentations","authorised.","18. The marketing authorisation holder","shall also notify the Agency if the product","ceases to be placed on the market, either","temporarily or permanently, and it shall","provide a justification on medical and/or","economic grounds in this respect."],"old":["","","","","","","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"244","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-245","location":[[" Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 d (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Article 39d","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices","1. The Committee for the Authorisation of","In Vitro Diagnostic Medical Devices shall","be composed of the following:","(a) one member and one alternate","member appointed by each Member State,","in accordance with paragraph 3 of this","Article;","(b) six members appointed by the","Commission, with a view to ensuring that","the relevant expertise in the field of","medical devices is available within the","Committee, on the basis of a public call","for expressions of interest;","(c) one member and one alternate","member appointed by the Commission, on","the basis of a public call for expressions","of interest, after consulting the European","Parliament, in order to represent","healthcare professionals;","(d) one member and one alternate","member appointed by the Commission, on","the basis of a public call for expressions","of interest, after consulting the European","Parliament, in order to represent patient","organisations.","The alternate members shall represent","and vote for the members in their","absence. The alternate members referred","to in point (a) may be appointed to act as","rapporteurs in accordance with Article 62","of Regulation (EC) 726/2004.","2. A Member State may delegate its tasks","in the Committee for the Authorisation of","In Vitro Diagnostic Medical Devices to","another Member State. Each Member","State may represent no more than one","other Member State.","3. The members and alternate members of","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall be","appointed on the basis of their relevant","expertise in the field of in vitro diagnostic","medical devices, in order to guarantee the","highest levels of specialist qualifications","and a broad spectrum of relevant","expertise. For this purpose, Member","States shall liaise with the Management","Board of the Agency and the Commission","in order to ensure that the final","composition of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices covers the scientific","areas relevant to its tasks.","4. The members and alternate members of","the Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall be","appointed for a term of three years, which","may be prolonged once and thereafter","renewed following the procedures","referred to in paragraph 1. The","Committee shall elect its Chairperson","from among its full members for a term of","three years, which may be prolonged","once.","5. Paragraphs 3, 4, 5, 6, 7 and 8 of Article","61 of Regulation (EC) 726/2004 shall","apply to the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices.","6. The mandate of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices shall cover all aspects of","the evaluation of medical devices in the","scope of the procedures under Articles","39c and 39f ;"],"old":["",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"245","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-134","justification":"To achieve the best possible protection of the subject, it is necessary to make authorisation by\nthe Member States contingent on the decision of the interdisciplinary and independent Ethics\nCommittee.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 7 \u2013 point 58 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["(58a) \u2018ethics committee\u2019 means an","independent body in a Member State","ensuring that the rights, safety and well-","being of subjects are protected. It shall act","in accordance with the laws and","regulations of the country or countries in","which the research is to be conducted and","shall abide by all relevant international","norms and standards. The Ethics","Committee shall consist of a reasonable","number of members who collectively","possess the relevant qualifications and","experience to be able to review and","evaluate the scientific, medical and","ethical aspects of the proposed test."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"134","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-246","location":[[" Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 e (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:40"},"new":["Article 39e","Decentralised procedure","1. Member States shall verify through the","electronic system on marketing","authorisations referred to in Article 39b","that no other application is currently","being reviewed, and that no other","marketing authorisation has been granted","for the same medical device.","2. Where a Member State notes that","another application for a marketing","authorisation for the same in vitro","diagnostic medical device is being","examined in another Member State, the","Member State concerned shall decline to","assess the application and immediately","inform the applicant.","3. Where a Member State has authorised","a in vitro diagnostic medical device which","is the subject of an application for a","marketing authorisation in another","Member State, the latter shall reject the","application and immediately inform the","applicant.","4. Member States shall take all","appropriate measures to ensure that the","procedure for granting a marketing","authorisation for devices referred to in","Article 39a (2) is completed within a","maximum of 210 days after the","submission of a valid application.","5. The competent national authority of a","Member State may only once request to","the manufacturer to submit additional","information that, for scientifically valid","grounds, is necessary for the assessment","of the application for marketing","authorisation. This may include a request","for samples or an on-site visit to the","manufacturer's premises. Until","submission of the additional information","requested, and within 60 days maximum,","the period referred to in paragraph 4 shall","be suspended.","6. If an applicant withdraws an","application for a marketing authorisation","submitted to the competent authority of a","Member States before an opinion on the","application has been given, the applicant","shall communicate its reasons for doing","so to the competent authority of that","Member State. The national competent","authority shall make this information","publicly accessible and shall publish the","assessment report, if available, after","deletion of all information of a","commercially confidential nature.","7. As soon as the marketing authorization","is issued, the applicant shall be informed","by the competent authority of the Member","State concerned.","8. The national competent authority shall,","without delay, and within 15 days, make","publicly available the marketing","authorisation.","9. The national competent authority shall","draw up an assessment report and make","comments on the file, notably as regards","the result of the clinical investigations","and the risk management system.","10. The national competent authority,","after deletion of all information of a","commercially confidential nature, shall","make the assessment report publicly","accessible without delay, and at the latest","within 15 days, together with the reasons","for its opinion.","11. Member States shall inform the","Agency of any marketing authorisation","that they have granted.","12. After a marketing authorisation has","been granted, the marketing authorisation","holder shall inform the competent","authority of the authorising Member State","of the date of the actual placing on the","market of the medical device in that","Member State.","13. The marketing authorisation holder","shall also notify the competent authority if","the medical device ceases to be placed on","the market of the Member State, either","temporarily or permanently, and it shall","provide a justification in this respect on","medical and/or economic grounds."],"old":["",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"246","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-135","location":[[" Proposal for a regulation","Chapter 2 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["Chapter II Chapter VI","Making available of devices, obligations of","economic operators, CE marking, free","movement"],"old":["","Making available of devices, obligations","of economic operators, CE marking, free","movement"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"135","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-247","location":[[" Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 f (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39f","Mutual recognition of decentralised","marketing authorisation","1. The MDCG as established by Article 76","shall be responsible for the examination","of any question relating to a marketing","authorisation in more than one Member","State of a medical device eligible for","authorisation in accordance with the","procedure laid down in Article 39e.","2. With a view to the granting of a","marketing authorisation for such an in","vitro diagnostic medical device in more","than one Member State, an applicant","shall submit an application based on an","identical dossier to the competent","authority in these Member States. The","dossier shall contain the information and","documents referred to in Annexes VIII,","IX and X of this Regulation. The","documents submitted shall include a list","of the Member States concerned by the","application. The applicant shall request","one Member State to act as 'reference","Member State' and to prepare an","assessment report on the in vitro","diagnostic medical device in accordance","with paragraphs 3 or 4.","3. Where the in vitro diagnostic medical","device has already been granted a","marketing authorisation at the time of","application, the concerned Member States","shall recognise the marketing","authorisation granted by the reference","Member State which shall be the Member","State that has first issued the marketing","authorisation. To this end, the marketing","authorisation holder shall request the","reference Member State to update the","existing assessment report of the","authorised in vitro diagnostic medical","device. The reference Member State shall","update the assessment report within 90","days of receipt of a valid application. The","assessment report together with other","relevant information and documents shall","be sent to the concerned Member States","and to the applicant.","4. In cases where the in vitro diagnostic","medical device has not received a","marketing authorisation at the time of","application, the applicant shall request","the reference Member State to prepare a","draft assessment report. The reference","Member State shall prepare the report","within 120 days after receipt of a valid","application and it shall send them to the","Member States concerned and to the","applicant.","5. Within 90 days of receipt of the","documents referred to in paragraphs 3","and 4, the Member States concerned shall","approve the assessment report and shall","inform the reference Member State","accordingly. The reference Member State","shall record the agreement of all parties,","close the procedure and inform the","applicant accordingly.","6. Each Member State in which an","application has been submitted in","accordance with paragraph 2 shall adopt","a decision in conformity with the","assessment report as approved, within 30","days after acknowledgement of the","agreement.","7. If, within the period laid down in","paragraph 5, a Member State concerned","cannot approve the assessment report on","the ground of a potential serious risk to","public health, it shall give a detailed","description of the reasons for its position","to the reference Member State, to the","other Member States concerned and to the","applicant. The points of disagreement","shall be forthwith referred to the MDCG.","8. Within the MDCG, all Member States","referred to in paragraph 7 shall","endeavour to reach agreement on the","action to be taken. They shall concede the","applicant the opportunity to make his","point of view known orally or in writing.","If, within 60 days of the communication","of the points of disagreement, the Member","States reach an agreement, the reference","Member State shall record the agreement,","close the procedure and inform the","applicant accordingly. Paragraph 6 shall","apply.","9. If the Member States fail to reach an","agreement within the 60-day period laid","down in paragraph 7, the Agency shall be","informed immediately, with a view to the","application of the procedure under Article","39g. The Agency shall be provided with a","detailed statement of the matters on which","the Member States have been unable to","reach agreement and the reasons for their","disagreement. A copy shall be transmitted","to the applicant.","10. As soon as the applicant is informed","that the matter has been referred to the","Agency, he shall forthwith forward to the","Agency a copy of the information and","documents referred to in paragraph 2.","11. In the circumstances referred to in","paragraph 9, Member States that have","approved the assessment report of the","reference Member State may, at the","request of the applicant, authorise the","medical device without waiting for the","outcome of the procedure laid down in","Article 39g. In that event, the","authorisation granted shall be without","prejudice to the outcome of that","procedure."],"old":["","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"247","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-136","justification":"In-vitro devices manufactured within a single health institution and used for patients must be\npublicly known thereby allowing Member States to ensure appropriate safety requirements to\nthese devices.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution\u2019s single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States are to","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and shall make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"old":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution\u2019s single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"136","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-248","location":[["Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 g (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39g","Arbitration procedure in the event of","disagreement over mutual recognition of","decentralised marketing authorisation","1. Where reference is made to the","procedure laid down in this Article, the","Committee on Medical Devices referred to","in Article 84(1) shall consider the matter","concerned and shall issue a reasoned","opinion within 60 days of the date on","which the matter was referred to it.","In urgent cases, and on a proposal from","its Chairperson, the Committee may agree","to a shorter deadline.","2. In order to consider the matter, the","Committee on Medical Devices shall","appoint one of its members to act as","rapporteur. The Committee may also","appoint individual experts to advise it on","specific questions. When appointing","experts, the Committee shall define their","tasks and specify the time-limit for the","completion of these tasks.","3. Before issuing its opinion, the","Committee on Medical Devices shall","provide the applicant or the marketing","authorisation holder with an opportunity","to present written or oral explanations","within a time limit which it shall specify.","The Committee may suspend the time","limits referred to in paragraph 1 in order","to allow the applicant or the marketing","authorisation holder to prepare","explanations.","4. The Agency shall forthwith inform the","applicant or the marketing authorisation","holder of the opinion of the Committee on","the marketing authorisation of the in vitro","diagnostic medical device concerned.","Within 15 days after receipt of the opinion","of the Committee on Medical Devices, the","applicant or the marketing authorisation","holder may notify the Agency in writing of","his intention to request a re-examination","of the opinion. In that case, he shall","forward to the Agency the detailed","grounds for the request within 60 days","after receipt of the opinion.","Within 60 days following receipt of the","grounds for the request, the Committee","shall re-examine its opinion. It shall","appoint a different rapporteur and, where","necessary, a different co-rapporteur from","the rapporteur and co-rapporteur","appointed for the initial opinion. The re-","examination procedure shall deal only","with the points of the opinion identified by","the applicant or the marketing","authorisation holder and shall be based","only on the scientific data available when","the Committee adopted the initial opinion.","The applicant or the marketing","authorisation holder may request that the","Committee consult the advisory committee","as established by Article 78a of","Regulation (EU) [Ref. future Regulation","on medical devices] in connection with","the re-examination.","The reasons for the conclusion reached in","the re-examination shall be annexed to","the assessment report referred to in","paragraph 5 of this Article.","5. Within 15 days after its adoption, the","Agency shall transmit the final opinion of","the Committee on Medical Devices to the","Member States, to the Commission and to","the applicant or the marketing","authorisation holder, together with the","assessment report of the in vitro","diagnostic medical device and stating the","reasons for its conclusions.","In the event of a favourable opinion","concerning the application for a mutual","recognition of decentralised marketing","authorisation for a medical device as","referred to in Article 39f, the following","documents shall be annexed to the","opinion:","(a) the dossier documents, as referred to","in Article 39f (2);","(b) any conditions that might be affecting","the authorisation;","(c) details of any recommended conditions","or restrictions with regard to the safe and","effective use of the in vitro diagnostic","medical device;","(d) the proposed text of the labelling and","leaflet for the medical device.","6. Within 15 days of the receipt of the","opinion referred to in paragraph 5, the","Commission shall prepare a draft of the","decision to be taken in respect of the","application, taking into account Union","law.","In the event of a draft decision which","envisages the granting of a marketing","authorization, the documents referred to","in paragraph 5 shall be annexed.","Where the draft decision is not in","accordance with the opinion of the","Agency, the Commission shall also annex","a detailed explanation of the reasons for","the differences.","The draft decision shall be transmitted to","the Member States and the applicant or","the marketing authorisation holder.","Member States shall have 22 days to","submit their written observations on the","draft decision to the Commission.","However, if a decision has to be taken","urgently, a shorter time-limit may be set","by the Chairperson of the Committee on","Medical Devices according to the degree","of urgency involved. That time limit shall","not, other than under exceptional","circumstances, be shorter than 5 days.","7. Member States may request in writing","that the draft decision referred to in","paragraph 6 be discussed by a plenary","meeting of the Committee on Medical","Devices, as referred to in Article 84(1),","stating their reasons in detail.","Where, in the opinion of the Commission,","a Member State's written observations","raise important new questions of a","scientific or technical nature which the","opinion delivered by the Agency has not","addressed, the Chairperson of the","Committee on Medical Devices shall","suspend the procedure and refer the","application back to the Agency for further","consideration.","8. The Commission shall take a final","decision in accordance with, and within","30 days after the end of, the procedure","referred to in Article 84(3). The","Commission shall update the information","on the concerned device in the electronic","system referred to in Article 39b.","9. A refusal of a marketing authorisation","shall constitute a prohibition on the","placing on the market of the concerned","device throughout the Union.","10. The decision as referred to in","paragraph 8 shall be addressed to all","Member States and transmitted to the","marketing authorisation holder or the","applicant. The concerned Member States","and the reference Member State shall","either grant or revoke the marketing","authorisation, or vary its terms as","necessary to comply with the decision","within 30 days following its notification.","They shall inform the Commission and","the Agency accordingly."],"old":["","","","","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"248","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-137","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:41"},"new":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to laboratory-developed tests","manufactured and used only within a single","health institution, provided manufacture","and use occur solely under the health","institution\u2019s single quality management","system, and the health institution is","accredited to standard EN ISO 15189 or","any other equivalent recognised standard.","Member States may require that the health","institutions submit to the competent","authority a list of such devices which have","been manufactured and used on their","territory and may make the manufacture","and use of the devices concerned subject to","further safety requirements."],"old":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set","out in Annex VII, and manufactured and","used only within a single health institution,","provided manufacture and use occur solely","under the health institution\u2019s single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"137","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-249","location":[["Proposal for a regulation","Chapter 5 \u2013 Section 1 a \u2013 Article 39 h (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39h","Variation to a marketing authorisation","1. Any application by the marketing","authorization holder to vary a marketing","authorization which has been granted in","accordance with the provisions of Articles","39c, 39e and 39f shall be submitted to all","the Member States which have previously","authorized the in vitro diagnostic medical","device concerned.","The Commission shall, in consultation","with the Agency, be empowered to adopt","delegated acts in accordance with Article","85 of this Regulation in order to adopt the","appropriate arrangements for the","examination of variations to the terms of","a marketing authorization.","2. In case of arbitration submitted to the","Commission, the procedure laid down in","Article 39g shall apply by analogy to","variations made to marketing","authorizations.","3. Where a Member State considers that","the variation of a marketing authorization","which has been granted in accordance","with the provisions of this Chapter or its","suspension or withdrawal is necessary for","the protection of public health, the","Member State concerned shall forthwith","refer the matter to the Agency for the","application of the procedure laid down in","Article 39g.","In exceptional cases, where urgent action","is essential to protect public health, until a","definitive decision is adopted, a Member","State may suspend the marketing and the","use of the device concerned on its","territory. It shall inform the Commission,","the Agency and the other Member States","no later than the following working day of","the reasons for this measure."],"old":["",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"249","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor, Linda McAvan, Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-138","justification":" The corrected terminology is \u2018accredited to\u2019","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[112620,2327,96944],"meta":{"created":"2019-07-03T05:26:41"},"new":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution\u2019s single quality","management system, and the health","institution is accredited to standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"old":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution\u2019s single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"138","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-250","location":[[" Proposal for a regulation","Article 39 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 a","Marketing authorisation procedure","1. Devices of class D may only be placed","on the market within the Union when a","Union marketing authorisation has been","granted through the centralised procedure","referred to in Article 41c, and in","accordance with the provisions of this","Regulation.","2. Devices referred to in paragraphs 1 and","which are already on the Union market at","the date of entry into force of this","Regulation, shall be required to have a","marketing authorisation, in accordance","with the procedures set out in this Section,","as from the expiry date of the validity of","their certificate.","3. A marketing authorisation granted","under this Section shall be valid for five","years. The marketing authorisation may","be renewed after five years on the basis of","a re-evaluation of the risk-benefit balance","by the Agency.","4. All applications for marketing","authorisation and granted marketing","authorisations under the provisions of","Articles 41c, 41d, 41e and 41f as well as","the information referred to in Article 41b","shall be entered either by the Commission","or the Member States, as relevant, in the","electronic system referred to in Article","41b(1), without delay and at the latest 15","days after receipt. Before commencing the","review of an application for a medical","device, the Committee for the","Authorisation of Medical Devices, as","referred to in Article 41c, or the","competent authority of the relevant","Member State shall verify that no other","application has been introduced for the","same medical device."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"250","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-251","location":[[" Proposal for a regulation","Article 39 b (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 b","Electronic system on marketing","authorisations","1. The Commission shall, in collaboration","with the Member States, set up and","manage an electronic registration system","for the applications for marketing","authorisations and granted marketing","authorisations under this Section and to","collate and process the following","information:","- the name of the manufacturer,","- the name of the in vitro diagnostic","medical device,","- the documentation accompanying the","application for a marketing authorisation,","- the assessment report for the in vitro","diagnostic medical device issued during","the marketing authorisation procedure,","- the date of the marketing authorisation","approval and, where different, the date on","which the device is placed on the market,","- any information regarding the","suspension or withdrawal of the","marketing authorisation.","2. The information collated and processed","shall be entered into the electronic","registration system by the European","Medicines Agency.","3. In case where this information needs to","be updated, with regards to placing of the","device on the market, the suspension or","withdrawal of the device from the market,","the manufacturer shall immediately","inform the Agency, who shall immediately","update the information in the electronic","system.","4. The information collated and processed","in the electronic system which relates to","applications for marketing authorisations","shall be accessible only to the Member","States, the Agency and the Commission.","The information collated and processed in","the electronic system and which relates to","granted marketing authorisations shall be","accessible to the public."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"251","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-139","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:41"},"new":["deleted"],"old":["Devices classified as class D in","accordance with the rules set out in","Annex VII, even if manufactured and","used within a single health institution,","shall comply with the requirements of this","Regulation. However, the provisions","regarding CE marking set out in Article","16 and the obligations referred to in","","","Articles 21 to 25 shall not apply to those","devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"139","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-252","location":[["Proposal for a regulation","Article 39 c (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 c","Centralised procedure","1. A Committee for the Authorisation of","In Vitro Diagnostic Medical Devices is","hereby established in accordance with the","provisions of Article 39d. The Committee","shall be part of the European Medicines","Agency.","2. The Committee for the Authorisation of","In Vitro Diagnostic Medical Devices shall","be responsible for drawing up the opinion","of the Agency on any matter concerning","the admissibility of applications submitted","in accordance with the centralised","procedure.","3. Each application for the devices","referred to in Article 39a (1) shall include","the particulars and documents as referred","to in Annexes VII, VIII, IX and X, as","relevant.","4. The application shall be accompanied","by the fee payable to the Agency for","examining the application.","5. The Agency shall ensure that the","opinion of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices is issued within 210 days","from receipt of a valid application. The","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall be","given at least 80 days from receipt of an","application for analysing the scientific","data in the documentation accompanying","an application for a marketing","authorisation. On the basis of a duly","reasoned request, from the Committee for","the Authorisation of In Vitro Diagnostic","Medical Devices, the Agency may extend","that period.","6. The Committee may only once request","the manufacturer to submit additional","information that for scientifically valid","grounds is necessary for the assessment of","the application for marketing","authorisation. Where such a request has","been made, the period referred to in","paragraph 5 shall be suspended until the","additional information requested has been","supplied.","7. The Commission shall, in consultation","with the Agency, the Member States and","interested parties, draw up a detailed","guide concerning the form in which","applications for authorisation are to be","presented.","8. Where the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices considers it necessary in","order to complete its examination of an","application, it may require the applicant","to undergo a specific inspection of the","manufacturing site of the in vitro","diagnostic medical device concerned.","Such inspections shall be made","unannounced. The inspection shall be","carried out within the time-limit laid down","in paragraph 5 by inspectors from the","Member State holding the appropriate","qualifications. Those inspectors may be","accompanied by a rapporteur or an expert","appointed by the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices.","9. The Agency shall forthwith inform the","applicant if the opinion of the Committee","for the Authorisation of In Vitro","Diagnostic Medical Devices is that:","(a) the application does not satisfy the","criteria for authorisation set out in this","Regulation;","(b) the documentation accompanying the","application is not in compliance with the","provisions of this Regulation or needs to","be amended or supplemented;","(c) the marketing authorisation needs to","be granted subject to certain conditions.","(d) the marketing authorisation for the in","vitro diagnostic medical device concerned","needs to be refused on grounds that the","device does not comply with this","Regulation.","10. Within 15 days of receipt of the","opinion referred to in paragraph 9, the","applicant may notify the Agency in","writing of his intention to request a","reexamination of the opinion. In such a","case, the applicant shall transmit to the","Agency the detailed grounds for such a","request within 60 days of receipt of the","opinion. Within 60 days following receipt","of the grounds for the request, the","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall re-","examine its opinion. The Committee for","the Authorisation of In Vitro Diagnostic","Medical Devices shall appoint a different","rapporteur and, where necessary, a","different co-rapporteur from those","appointed for the initial opinion. The re-","examination procedure may deal only","with the points of the opinion initially","identified by the applicant and may be","based only on the scientific data available","when the Committee for the Authorisation","of In Vitro Diagnostic Medical Devices","adopted the initial opinion. The applicant","may request that the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices consult a scientific","advisory group in connection with the re-","examination.","11. Within 15 days from its adoption, the","Agency shall send the final opinion of the","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices to the","Commission, the Member States and the","applicant, together with a report","describing the assessment of the medical","device by the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices and stating the reasons","for its conclusions.","12. If an applicant withdraws an","application for a marketing authorisation","submitted to the Agency before an opinion","has been issued concerning that","application, the applicant shall","communicate its reasons for withdrawal","to the Agency. The Agency shall make","this information publicly available and","shall publish the assessment report, if","available, after deleting all information of","a commercially confidential nature.","13. Within 15 days of receipt of the","opinion referred to in paragraph 11, the","Commission shall prepare a draft of the","decision to be taken in respect of the","application. Where the draft decision","diverges from the opinion of the Agency,","the Commission shall annex a detailed","explanation of the reasons for the","differences. The draft decision shall be","transmitted to the Member States and the","applicant. Member States shall have 22","days to submit their written observations","on the draft decision to the Commission.","However, if a decision has to be taken","urgently, a shorter time-limit may be set","by the Chairperson of the Committee on","In Vitro Diagnostic Medical Devices","according to the degree of urgency","involved. This time-limit shall not,","otherwise than in exceptional","circumstances, be shorter than 5 days;","14. Member States may request in writing","that the draft decision referred to in","paragraph 13 be discussed by a plenary","meeting of the Committee on In Vitro","Diagnostic Medical Devices, stating their","reasons in detail. Where, in the opinion of","the Commission, a Member State's written","observations raise important new","questions of a scientific or technical","nature which the opinion delivered by the","Agency has not addressed, the","Chairperson of the Committee on In Vitro","Diagnostic Medical Devices shall suspend","the procedure and refer the application","back to the Agency for further","consideration.","15. The Commission shall take a final","decision within 30 days from the end of","the examination procedure referred to in","Article [...].","16. The refusal of a marketing","authorisation shall constitute a","prohibition on the placing on the market","of the devices referred to in Article 39a(1)","throughout the Union.","17. After a marketing authorisation has","been granted, the marketing authorisation","holder shall inform the Agency of the","dates of actual placing on the market of","the medical device in the Member States,","taking into account the various","presentations authorised.","18. The marketing authorisation holder","shall also notify the Agency if the product","ceases to be placed on the market, either","temporarily or permanently, and it shall","provide a justification on medical and/or","economic grounds in this respect."],"old":["","","","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"252","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-253","location":[[" Proposal for a regulation","Article 39 d (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 d","Committee for the Authorisation of In","Vitro Diagnostic Medical Devices","1. The Committee for the Authorisation of","In Vitro Diagnostic Medical Devices shall","be composed of the following:","(a) one member and one alternate","member appointed by each Member State,","in accordance with paragraph 3 of this","Article;","(b) six members appointed by the","Commission, with a view to ensuring that","the relevant expertise in the field of","medical devices is available within the","Committee, on the basis of a public call","for expressions of interest;","(c) one member and one alternate","member appointed by the Commission, on","the basis of a public call for expressions","of interest, after consulting the European","Parliament, in order to represent","healthcare professionals;","(d) one member and one alternate","member appointed by the Commission, on","the basis of a public call for expressions","of interest, after consulting the European","Parliament, in order to represent patient","organisations. The alternate members","shall represent and vote for the members","in their absence. The alternate members","referred to in point (a) may be appointed","to act as rapporteurs in accordance with","Article 62 of Regulation (EC) 726/2004.","2. A Member State may delegate its tasks","in the Committee for the Authorisation of","Medical Devices to another Member","State. Each Member State may represent","no more than one other Member State.","3. The members and alternate members of","the Committee for the Authorisation of","Medical Devices shall be appointed on the","basis of their relevant expertise in the","field of medical devices, in order to","guarantee the highest levels of specialist","qualifications and a broad spectrum of","relevant expertise. For this purpose,","Member States shall liaise with the","Management Board of the Agency and","the Commission in order to ensure that","the final composition of the Committee","for the Authorisation of In Vitro","Diagnostic Medical Devices covers the","scientific areas relevant to its tasks.","4. The members and alternate members of","the Committee for the Authorisation of In","Vitro Diagnostic Medical Devices shall be","appointed for a term of three years, which","may be prolonged once and thereafter","renewed following the procedures","referred to in paragraph 1. The","Committee shall elect its Chairperson","from among its full members for a term of","three years, which may be prolonged","once.","5. Paragraphs 3, 4, 5, 6, 7 and 8 of Article","61 of Regulation (EC) 726/2004 shall","apply to the Committee for the","Authorisation of Medical Devices.","6. The mandate of the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices shall cover all aspects of","the evaluation of medical devices in the","scope of the procedures under Articles","39c;"],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"253","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-140","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:41"},"new":["Devices classified as class D in accordance","with the rules set out in Annex VII, if","manufactured and used within a single","health institution, shall be exempt from the","requirements of this Regulation, with the","exception of Article 59(4) and general","safety performance requirements set out","in Annex 1 where the following","conditions are met:","(a) the recipient patient or patient group\u2019s","specific needs can not be met by an","available CE-marked device;","(b) the health institution is accredited to","ISO standard 15189 quality management","system, or any other equivalent","recognised standard;","(c) the health institution provides the","competent authority referred to in Article","26 with a list of such devices, which shall","include a justification of their","manufacturing, modification or use, in","particular, where similar devices have","been made available on the market. This","information shall be made public.","Member States shall retain the right to","restrict the in-house manufacture and use","of any specific type of in-vitro diagnostic","device in relation to aspects that are not","covered by this Regulation, and may also","make the manufacture and use of the","devices concerned subject to further","safety requirements."],"old":["Devices classified as class D in accordance","with the rules set out in Annex VII, even if","manufactured and used within a single","health institution, shall comply with the","requirements of this Regulation. However,","the provisions regarding CE marking set","out in Article 16 and the obligations","referred to in Articles 21 to 25 shall not","apply to those devices.",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"140","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-254","location":[[" Proposal for a regulation","Article 39 e (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 e","The actors in the Committee for the","Authorisation of In Vitro Diagnostic","Medical Devices shall undertake to act","independently in the public interest. Prior","to taking up their duties, they shall make","available a declaration of commitment","and a declaration of interests indicating","either the absence of any interests which","might be considered prejudicial to their","independence or any direct or indirect","interests which might be prejudicial to","their independence. Those declarations","shall be verified by the Commission."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"254","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor, Linda McAvan, Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-141","justification":" The proposal removes the possibility of health institutions producing or modifying class D\n devices. There are patient needs for which there are no commercially available IVD Devices,\n\nsuch as the diagnosis of very rare diseases, or the identification of emerging pathogens.\nHealth institutions play a vital role in protecting public health, by manufacturing these\ndevices in-house. These amendments seek to maintain this public health function whilst\nensuring patient safety is paramount.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[112620,2327,96944],"meta":{"created":"2019-07-03T05:26:41"},"new":["Devices classified as class D in accordance","with the rules set out in Annex VII, if","manufactured and used within a single","health institution, shall be exempt from the","requirements of this Regulation, with the","exception of Article 59(4), where the","following conditions are met;","(a) the recipient patient or patient group\u2019s","specific needs can not be met by an","available CE-marked device;","(b) the health institution is accredited to","EN ISO standard 15189 quality","management system, or any other","equivalent recognised standard;","(c) the health institution provides their","competent authority referred to in Article","26 with a list of such devices, which shall","include a justification of their","manufacturing or modification, in","particular, where similar devices have","been made available on the market. This","information shall be updated yearly, and","shall be made public."],"old":["Devices classified as class D in","accordance with the rules set out in Annex","VII, even if manufactured and used within","a single health institution, shall comply","with the requirements of this Regulation.","However, the provisions regarding CE","marking set out in Article 16 and the","obligations referred to in Articles 21 to 25","shall not apply to those devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"141","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-255","location":[[" Proposal for a regulation","Article 39 f (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Article 39 f","Variation to a marketing authorisation","1. Any application by the marketing","authorization holder to vary a marketing","authorization which has been granted in","accordance with the provisions of Article","41c shall be submitted to the Commission.","The Commission shall, in consultation","with the Agency, be empowered to adopt","delegated acts in accordance with Article","89 of this Regulation in order to adopt the","appropriate arrangements for the","examination of variations to the terms of","a marketing authorization.","2. Where a Member State considers that","the variation of a marketing authorization","which has been granted in accordance","with the provisions of this Chapter or its","suspension or withdrawal is necessary for","the protection of public health, the","Member State concerned may request a","discussion by a plenary meeting of the","Committee on In Vitro Diagnostic","Medical Devices, stating their reasons in","detail. In exceptional cases where, in the","opinion of the Commission, a Member","State's written observations raise","important new questions of a scientific or","technical nature which the authorisation","delivered has not addressed, the","Chairperson of the Committee on In Vitro","Diagnostic Medical Devices shall suspend","the authorization and refer the","application to the Agency for further","consideration."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"255","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor, Linda McAvan, Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-142","justification":"The proposal removes the possibility of health institutions producing or modifying class D\ndevices. There are patient needs for which there are no commercially available IVD Devices,\nsuch as the diagnosis of very rare diseases, or the identification of emerging pathogens.\nHealth institutions play a vital role in protecting public health, by manufacturing these\ndevices in-house. These amendments seek to maintain this public health function whilst\nensuring patient safety is paramount.","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 5 a (new)"]],"meps":[112620,2327,96944],"meta":{"created":"2019-07-03T05:26:41"},"new":["5a. Member States shall retain the right to","restrict the in-house manufacture and use","of any specific type of in-vitro diagnostic","device in relation to aspects that are not","covered by this Regulation, and may also","make the manufacture and use of the","devices concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"142","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-256","location":[["Proposal for a regulation","Article 40 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:41"},"new":["Manufacturers of devices classified as class","D, other than devices for performance","evaluation, shall be subject to a centralised","marketing authorisation procedure."],"old":["Manufacturers of devices classified as","class D, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality","","","assurance, design dossier examination","and batch verification, as specified in","Annex VIII. Alternatively, the","manufacturer may choose to apply a","conformity assessment based on type","examination as specified in Annex IX,","coupled with a conformity assessment","based on production quality assurance","including batch verification, as specified","in Annex X."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"256","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-257","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["Manufacturers of devices classified as class","D, other than devices for performance","evaluation, shall be subject to a marketing","authorisation based on full quality","assurance, design dossier examination and","batch verification, as specified in Annex","VIII. Alternatively, the manufacturer may","choose to apply a marketing authorisation","based on type examination as specified in","Annex IX, coupled with a marketing","authorisation based on production quality","assurance including batch verification, as","specified in Annex X."],"old":["Manufacturers of devices classified as","class D, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality assurance,","design dossier examination and batch","verification, as specified in Annex VIII.","Alternatively, the manufacturer may","choose to apply a conformity assessment","based on type examination as specified in","Annex IX, coupled with a conformity","assessment based on production quality","assurance including batch verification, as","specified in Annex X."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"257","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber, Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-143","justification":" This new article refers to long-standing requests of the European Parliament and other\n international institutions like the Council of Europe and OECD. Genetic tests should be\n performed by a medical professional after appropriate genetic counselling. Informed consent\n is a prerogative of the Charta of Fundamental Rights and should therefore be introduced in\n the legislation.","location":[["Proposal for a regulation","Article 4 a (new)"]],"meps":[28227,1927],"meta":{"created":"2019-07-03T05:26:42"},"new":["Article 4a","Genetic information, counselling and free","consent","1. A device may only be used for the","purpose of a genetic test if that test is","conducted by persons admitted to the","medical profession under the applicable","national legislation.","2. A product may only be used for the","purposes of a genetic test if the rights,","safety and well-being of the test subjects","are protected and the clinical data","generated in the course of the testing are","expected to be reliable and robust.","3. Before using a device for the purpose of","a genetic test the person referred to in","paragraph 1 shall provide the test subject","concerned with appropriate information","on the nature, the significance and the","implications of the genetic test.","4. Before using a device for the purpose of","a genetic test the person referred to in","paragraph 1 shall provide the test subject","concerned with appropriate and","comprehensible genetic counselling","without prejudging the outcome. The","genetic counselling shall include medical,","ethical, social, psychological and legal","aspects.","The form and extent of that genetic","counselling shall be defined according to","the implications of the results of the test","and their significance for the person or","the members of that person\u2019s family,","including possible implications","concerning procreation choices.","5. A device may only be used for the","purpose of a genetic test after the test","subject concerned has given free and","informed consent to it. That consent shall","be given explicitly in writing. The consent","may be revoked at any time in writing or","orally.","6. In the case of minors, the informed","consent of the parents or legal","representative shall be obtained. That","consent shall represent the minor\u2019s","presumed will and may be revoked at any","time, without detriment to the minor. In","the case of incapacitated adults who are","unable to give informed legal consent, the","informed consent of the legal","representative shall be obtained. The","consent shall represent the presumed will","of the person concerned and may be","revoked at any time, without detriment to","that person.","Devices providing an indication of a","genetic disease which develops in","adulthood or affects family planning may","not be used on minors unless preventive","treatment is available and can be provided","before the person being tested reaches the","age at which he or she can give informed","consent.","7. No prenatal genetic examination","designed to detect the genetic","predisposition of an embryo or a foetus to","a disease may be conducted if, on the","basis of current medical knowledge and","technology, it is generally accepted that","the disease in question will not manifest","itself before the individual concerned","reaches the age of 18.","8. A device may only be used for the","determination of gender in connection","with prenatal diagnosis, if the","determination fulfils a medical purpose","and if there is a risk of serious gender","specific hereditary diseases. By way of","derogation from Article 2(1) and (2) the","same restriction on use shall apply to","products which are not intended to fulfil a","specific medical purpose.","9. The provisions of this Article on the use","of devices for the purpose of genetic tests","shall not prevent Member States from","maintaining or introducing for reasons of","health protection or public order more","stringent national legislation in this field."],"old":["",""],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"143","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-258","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["In addition, where a reference laboratory is","designated in accordance with Article 78,","the Committee for the Authorisation of In","Vitro Diagnostic Medical Device referred","to in Article 39c, or the national authority,","shall request that reference laboratory to","verify compliance of the device with the","applicable CTS, when available, or with","other solutions chosen by the manufacturer","to ensure a level of safety and performance","that is at least equivalent, as specified in","Section 5.4 of Annex VIII and in Section","3.5 of Annex IX."],"old":["In addition, where a reference laboratory","is designated in accordance with Article","78, the notified body performing the","conformity assessment shall request that","reference laboratory to verify compliance","of the device with the applicable CTS,","when available, or with other solutions","chosen by the manufacturer to ensure a","level of safety and performance that is at","least equivalent, as specified in Section 5.4","of Annex VIII and in Section 3.5 of Annex","IX."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"258","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Christel Schaldemose, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Mairead McGuinness, Richard Seeber, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-144","justification":" New element in paragraph 5 compared to the wording in the draft report (Amendment 30).\n This amendment clarifies also the purpose of Article 4a paragraph 4 after consultation with\n the shadows and experts. It needs to be made clear that genetic counselling is not mandatory\n when it just confirms a specific diagnosis and it is also not necessary for companion\n diagnostics or when the genetic test shows a normal finding.","location":[[" Proposal for a regulation","Article 4 a (new)"]],"meps":[1927,37312,113487,28161,21818,96914,96664,28221,39916,4282,28115,28252,28178],"meta":{"created":"2019-07-03T05:26:42"},"new":["Article 4a","1. A device may only be used for the","purpose of a genetic test if the indication","is given by persons admitted to the","medical profession under the applicable","national legislation after a personal","consultation.","2. A device may be used for purposes of a","genetic test only in a way that the rights,","safety and well-being of the subjects are","protected and that the clinical data","generated in the course of the genetic","testing are going to be reliable and robust.","3. Information. Before using a device for","the purpose of a genetic test the person","mentioned in paragraph 1 shall provide","the person concerned with appropriate","information on the nature, the","significance and the implications of the","genetic test.","4. Genetic counselling. Appropriate","genetic counselling is mandatory before","using a device for the purpose of","predictive and prenatal testing and after a","genetic condition has been diagnosed. It","shall include medical, ethical, social,","psychological and legal aspects and has to","be addressed by physicians qualified in","genetic counselling.","The form and extent of this genetic","counselling shall be defined according to","the implications of the results of the test","and their significance for the person or","the members of his or her family,","including possible implications","concerning procreation choices.","5. Consent. A device may only be used for","the purpose of a genetic test after the","person concerned has given free and","informed consent to it. The consent has to","be given explicitly and in writing. It can","be revoked at any time in writing or","orally.","6. Testing of minors. In case of minors","the informed consent of the parents or","legal representative shall be obtained;","consent must represent the minor\u2019s","presumed will and may be revoked at any","time, without detriment to the minor. In","case of incapacitated adults not able to","give informed legal consent, the informed","consent of the legal representative shall","be obtained; consent must represent the","presumed will and may be revoked at any","time, without detriment to the person.","Devices predicting a genetic condition","that has implications for diseases in","adulthood or for family planning shall not","be used in minors unless preventive","means are available before reaching the","age when the person tested is able to give","consent.","7. A device may only be used for the","determination of sex in connection with","prenatal diagnosis, if the determination","fulfils a medical purpose and if there is a","risk of serious gender specific hereditary","diseases. By way of derogation of Article","2(1) and (2) this also applies to products","which are not intended to fulfil a specific","medical purpose.","8. The provisions of this Article on the use","of devices for the purpose of genetic tests","do not prevent the Member States from","maintaining or introducing for reasons of","health protection or public order more","stringent national legislation in this field."],"old":["",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"144","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-259","justification":" Experiences with the current legislation call for a clear description that the involvement of\n reference laboratories means to perform testings and not paper investigations.","location":[["Proposal for a regulation","Article 40 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1927,28161,21818,96914,96664,28221,39916,4282,28178],"meta":{"created":"2019-07-03T05:26:41"},"new":["In addition, where a reference laboratory is","designated in accordance with Article 78,","the notified body performing the","conformity assessment shall request that","reference laboratory to verify by laboratory","testing compliance of the device with the","applicable CTS, as specified in Section 5.4","of Annex VIII and in Section 3.5 of","Annex IX. Laboratory tests performed by","a reference laboratory shall focus on in","particular analytic sensitivity and","specificity using reference materials and","diagnostic sensitivity and specificity using","specimens from early and established","infection."],"old":["In addition, where a reference laboratory","is designated in accordance with Article","78, the notified body performing the","conformity assessment shall request that","reference laboratory to verify compliance","of the device with the applicable CTS,","when available, or with other solutions","chosen by the manufacturer to ensure a","level of safety and performance that is at","least equivalent, as specified in Section","5.4 of Annex VIII and in Section 3.5 of","Annex IX."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"259","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-145","location":[[" Proposal for a regulation","Article 5 \u2013 paragraph 2"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:42"},"new":["2. A device that is not placed on the market","but is used in the context of a commercial","activity for the provision of a diagnostic or","therapeutic service offered by any means","of communication (including by means of","information society services) to a natural","or legal person established in the Union","shall comply with this Regulation."],"old":["2. Without prejudice to national","legislation regarding the exercise of the","medical profession, a device that is not","placed on the market but is used in the","context of a commercial activity for the","provision of a diagnostic or therapeutic","service offered by means of information","society services as defined in Article 1(2)","of Directive 98/34/EC or by other means","of communication to a natural or legal","person established in the Union shall","comply with this Regulation."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"145","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-260","justification":" This will change the path for companion Diagnostics to co-development of CTS between EMA\n and IVD experts from Notified bodies and competent authorities for IVD medical devices.","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 2 \u2013 subparagraph 3"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:41"},"new":["For companion diagnostics where a","reference laboratory has been designated","in accordance with Article 78, the notified","body performing the conformity","assessment shall request that reference","laboratory to verify compliance of the","device with the applicable CTS, when","available."],"old":["For companion diagnostics intended to be","used to assess the patient eligibility for","treatment with a specific medicinal","product, the notified body shall consult","one of the competent authorities","designated by the Member States in","accordance with Directive 2001/83/EC of","the European Parliament and of the","Council of 6 November 2001 on the","Community code relating to medicinal","products for human use or the European","Medicines Agency (EMA) in accordance","with the procedures set out in Section 6.2","of Annex VIII and in Section 3.6 of","Annex IX."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"260","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-146","justification":"Zapisy, kt\u00f3re zosta\u0142y zaproponowane przez Komisj\u0119 w projektach rozporz\u0105dze\u0144 nie s\u0105\nwystarczaj\u0105ce i tym samym nie zabezpieczaj\u0105 w przedmiotowym zakresie interes\u00f3w pa\u0144stw\ncz\u0142onkowskich. Utrzymanie propozycji komisyjnej, kt\u00f3ra zosta\u0142a ju\u015c ugruntowana w praktyce\norgan\u00f3w kompetentnych spowoduje, \u015ce w internecie b\u0119d\u0105 obecne reklamy wprowadzaj\u0105ce w\nb\u0142\u0105d potencjalnego nabywc\u0119 wyrob\u00f3w, gdy\u015c b\u0119dzie mo\u015cna oferowa\u0107 produkty, dla kt\u00f3rych nie\nprzeprowadzono procedury oceny zgodno\u015bci, a dopiero w momencie ich sprzeda\u015cy, b\u0119dzie\ntrzeba zapewni\u0107, \u015ce taki wyr\u00f3b spe\u0142nia wymagania. Jest to niepokoj\u0105ce i dlatego nale\u015cy\numo\u015cliwi\u0107 organom kompetentnym, mo\u015cliwo\u015b\u0107 zdobycia wiedzy, kto zamieszcza\u0142 takie\nog\u0142oszenia w przypadku otrzymania sygna\u0142u z rynku, \u015ce w\u0142a\u015bnie wyr\u00f3b niespe\u0142niaj\u0105cy\nwymaga\u0144, w tym nawet niebezpieczny dla zdrowia lub \u015cycia u\u015cytkownika, zosta\u0142 w taki spos\u00f3b\nsprzedany i aby dostarczyciele us\u0142ug internetowych udost\u0119pniali dane o podmiotach\nzamieszczaj\u0105cych reklamy wyrob\u00f3w w internecie.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 a (new)"]],"meps":[96753],"meta":{"created":"2019-07-03T05:26:42"},"new":["2a. Service providers providing means of","distance communication shall be obliged,","upon receiving a request from the","competent authority, to disclose the details","of entities engaging in distance selling."],"orig_lang":"pl","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"146","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-261","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:41"},"new":["By way of derogation from Article 39a,","manufacturers of devices classified as class","C, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality assurance,","as specified in Annex VIII, with","assessment of the design documentation","within the technical documentation on a","representative basis. Alternatively, the","manufacturer may choose to apply a","conformity assessment based on type","examination, as specified in Annex IX","coupled with conformity assessment based","on production quality assurance, as","specified in Annex X."],"old":["Manufacturers of devices classified as","class C, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality assurance,","as specified in Annex VIII, with","assessment of the design documentation","within the technical documentation on a","representative basis. Alternatively, the","manufacturer may choose to apply a","conformity assessment based on type","examination, as specified in Annex IX","coupled with conformity assessment based","on production quality assurance, as","specified in Annex X."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"261","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-262","justification":" This will change the path for companion Diagnostics to co-development of CTS between EMA\n and IVD experts from Notified bodies and competent authorities for IVD medical devices","location":[["Proposal for a regulation","Article 40 \u2013 paragraph 3 \u2013 subparagraph 3"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:42"},"new":["For companion diagnostic where a","reference laboratory is designated in","accordance with Article 78, the notified","body performing the conformity","assessment shall request that reference","laboratory to verify compliance of the","device with the applicable CTS, when","available."],"old":["For companion diagnostic intended to be","used to assess the patient eligibility to a","treatment with a specific medicinal","product, the notified body shall consult","one of the competent authorities","designated by the Member States in","accordance with Directive 2001/83/EC or","the European Medicines Agency (EMA)","in accordance with the procedures set out","in Section 6.2 of Annex VIII and in","Section 3.6 of Annex IX."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"262","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Jolanta Emilia Hibner","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-147","justification":" Kwestie podnoszone w powy\u015cszej poprawce, w og\u00f3le nie znalaz\u0142y si\u0119 w propozycjach nowych\n przepis\u00f3w. Nale\u015cy wprowadzi\u0107 zakaz reklamy wprowadzaj\u0105cej w b\u0142\u0105d, co do w\u0142a\u015bciwo\u015bci i\n przeznaczenia wyrob\u00f3w, gdy\u015c wp\u0142ynie to pozytywnie na ochron\u0119 europejczyk\u00f3w przed\n nieetycznym post\u0119powaniem, kt\u00f3re mo\u015ce doprowadzi\u0107 nawet do zaniechania w\u0142a\u015bciwego\n leczenia medycznego przy zastosowaniu wyrobu, kt\u00f3ry obiecywa\u0142 du\u015co, ale w zasadzie nie\n leczy lub nie udowodniono wskazania zawartego w instrukcjach o dane kliniczne. W obszarze\n produkt\u00f3w leczniczych regulacja idzie nawet dalej, gdy\u015c ka\u015cda reklama, powinna by\u0107\n zaopatrzona w stosowne zdanie informuj\u0105ce, \u015ce przed skorzystaniem z leku nale\u015cy skorzysta\u0107\n z konsultacji lekarza lub farmaceuty, jednak\u015ce dla wyrob\u00f3w medycznych wydaje si\u0119 na razie\n wystarczaj\u0105ce, aby zawrze\u0107 zaproponowane powy\u015cej przepisy.","location":[["Proposal for a regulation","Article 5 \u2013 paragraph 2 b (new)"]],"meps":[96753],"meta":{"created":"2019-07-03T05:26:42"},"new":["2b. There shall be a prohibition on the","marketing, placing in use, distribution,","delivery and making available of products","whose names, labelling or instructions for","use may mislead with regard to the","product\u2019s characteristics and effects by:","a) ascribing characteristics, functions and","effects to the product which the product","does not have;","b) creating the false impression that","treatment or diagnosis using the product","is sure to be successful, or failing to","inform of a likely risk associated with the","use of the product in line with its intended","use or for a longer-than-anticipated","period;","c) suggesting uses or characteristics of the","product other than those declared when","the conformity assessment was carried","out.","Promotional materials, presentations and","information about the products may not","mislead in the manner referred to in the","first sentence."],"old":[""],"orig_lang":"pl","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"147","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-263","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["By way of derogation from Article 39a,","manufacturers of devices classified as class","B, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality assurance,","as specified in Annex VIII."],"old":["Manufacturers of devices classified as","class B, other than devices for performance","evaluation, shall be subject to a conformity","assessment based on full quality assurance,","as specified in Annex VIII."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"263","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-264","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["By way of derogation from Article 39a,","manufacturers of devices classified as class","A, other than devices for performance","evaluation, shall declare the conformity of","their products by issuing the EU","declaration of conformity referred to in","Article 15, after drawing up the technical","documentation set out in Annex II."],"old":["Manufacturers of devices classified as","class A, other than devices for performance","evaluation, shall declare the conformity of","their products by issuing the EU","declaration of conformity referred to in","Article 15, after drawing up the technical","documentation set out in Annex II."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"264","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-148","justification":"This is shifting the consultation process to the development of Common Technical\nSpecifications for companion diagnostics, setting up minimal performance requirements for\nthose tests. Those minimal performance requirements would also be available to the users\nensuring a better transparency of the system. In addition, the consultation of EMA or\ncompetent authorities for medicinal products would not be appropriate in regard to the\nperformance of the IVD tests to be used together with the personalized medicine. None of\nthem have the necessary competences and mandate regarding the assessment of the safety and\nperformance of those tests.","location":[[" Proposal for a regulation","Article 7 \u2013 paragraph 1"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:42"},"new":["1. For Class D devices and as needed for","companion diagnostics, where no","harmonised standards exist or where there","is a need to address a public health","concern the Commission shall be","empowered to adopt common technical","specifications (CTS) in respect of the","general safety and performance","requirements set out in Annex I, the","technical documentation set out in Annex","II or the clinical evidence and post-market","follow-up set out in Annex XII. The CTS","shall be adopted by means of implementing","acts in accordance with the examination","procedure referred to in Article 84(3)."],"old":["1. Where no harmonised standards exist or","where relevant harmonised standards are","not sufficient, the Commission shall be","empowered to adopt common technical","specifications (CTS) in respect of the","","","general safety and performance","requirements set out in Annex I, the","technical documentation set out in Annex","II or the clinical evidence and post-market","follow-up set out in Annex XII. The CTS","shall be adopted by means of implementing","acts in accordance with the examination","procedure referred to in Article 84(3)."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"148","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-265","location":[["Proposal for a regulation","Article 40 \u2013 paragraph 6"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["6. Manufacturers may choose to apply a","marketing authorisation or a conformity","assessment procedure applicable to devices","of a higher class than the device in","question."],"old":["6. Manufacturers may choose to apply a","conformity assessment procedure","applicable to devices of a higher class than","the device in question."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"265","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-149","justification":"In the context of shifting from the consultation process to the development of Common\nTechnical Specifications for companion diagnostics, it must be ensured that the experts from\nall interested parties are involved. In particular, for the development of CTS on companion\n\n\n diagnostics, experts from the IVD sector as well as from competent authorities for medicinal\n products and/or from EMA shall be involved.","location":[["Proposal for a regulation","Article 7 \u2013 paragraph 3 a (new)"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:42"},"new":["3a. The relevant scientific experts from","the various interested parties shall be","involved in the drafting of the common","technical specifications."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"149","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-266","location":[["Proposal for a regulation","Article 40 \u2013 paragraph 9 \u2013 subparagraph 1 \u2013 indent 3"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["deleted"],"old":["\u2013 the frequency of samples of the","manufactured devices or batches of","devices classified as class D to be sent to a","reference laboratory designated under","Article 78 in accordance with Section 5.7","of Annex VIII and Section 5.1 of Annex","X, or"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"266","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-150","justification":" Technical data and clinical evidence submitted by manufacturers must be made publicly\n available to guarantee safe and quality products to the consumer.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:42"},"new":["2. Manufacturers shall draw up the","technical documentation which shall allow","assessment of the conformity of the device","with the requirements of this Regulation.","The technical documentation shall include","the elements set out in Annex II and be","made accessible to the public."],"old":["2. Manufacturers shall draw up the","technical documentation which shall allow","assessment of the conformity of the device","with the requirements of this Regulation.","The technical documentation shall include","the elements set out in Annex II."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"150","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-267","location":[["Proposal for a regulation","Article 41 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["Involvement of notified bodies in the","conformity assessment procedure"],"old":["Involvement of notified bodies"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"267","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-151","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:42"},"new":["deleted"],"old":["The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 amending or supplementing, in","the light of technical progress, the","elements in the technical documentation","set out in Annex II."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"151","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-268","location":[[" Proposal for a regulation","Article 41 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["1. Where the conformity assessment","procedure requires the involvement of a","notified body, the manufacturer may apply","to a notified body of his choice, provided","that the body is notified for the conformity","assessment activities, the conformity","assessment procedures and the devices","concerned. Where a manufacturer applies","to a notified body located in a Member","State other than the one where it is","registered, the manufacturer shall inform","its national authority responsible for the","notified bodies of the application. An","application may not be lodged in parallel","with more than one notified body for the","same conformity assessment activity."],"old":["1. Where the conformity assessment","procedure requires the involvement of a","notified body, the manufacturer may apply","to a notified body of his choice, provided","that the body is notified for the conformity","assessment activities, the conformity","assessment procedures and the devices","concerned. An application may not be","lodged in parallel with more than one","notified body for the same conformity","assessment activity."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"268","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-152","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 7 \u2013 subparagraph 2"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:42"},"new":["For devices for self-testing or near-patient-","testing, the information supplied in","accordance with Section 17 of Annex I","shall be easily understandable and","provided in the language(s) of the Member","State where the device reaches its intended","user."],"old":["For devices for self-testing or near-patient-","testing, the information supplied in","accordance with Section 17 of Annex I","shall be provided in the language(s) of the","Member State where the device reaches its","intended user."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"152","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-269","location":[[" Proposal for a regulation","Article 42"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:42"},"new":["Article deleted"],"orig_lang":"cs","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"269","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-153","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 8"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:42"},"new":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","distributors, importers and, where","applicable, the authorised representative","accordingly."],"old":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","distributors and, where applicable, the","authorised representative accordingly."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"153","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-270","justification":"If the safety of medical devices is to be enhanced, it is particularly vital that the role of\nnotified bodies should be strengthened. The use of the scrutiny procedure may mean that\nhighly innovative medical devices become available to patients only after a considerable\ndelay.","location":[["Proposal for a regulation","Article 42"]],"meps":[28227],"meta":{"created":"2019-07-03T05:26:42"},"new":["Article deleted"],"orig_lang":"de","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"270","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-154","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 8"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:42"},"new":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","responsible national competent authority,","the distributors and, where applicable, the","authorised representative accordingly."],"old":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","distributors and, where applicable, the","authorised representative accordingly."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"154","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-271","location":[["Proposal for a regulation","Article 42"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["deleted"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"271","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-155","justification":"To ensure that users will not lack access to information that would demonstrate the\ndefectiveness of in-vitro medical devices that has hurt the users, this new right to information\nwould redress the balance to the benefit of users.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 9"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:42"},"new":["9. Manufacturers shall, in response to a","reasoned request from a competent","authority, provide it with all the","information and documentation necessary","to demonstrate the conformity of the","device, in an official Union language","which can be easily understood by that","authority. They shall cooperate with that","authority, at its request, on any corrective","action taken to eliminate the risks posed by","devices which they have placed on the","market or put into service.","If facts exist that give reason to assume","that an in-vitro medical device has caused","damage, the potentially harmed user, his","successor in title, his compulsory health","insurance or other third parties affected","by the damage may also demand the","information referred to in sentence 1 from","the manufacturer or his authorised","representative.","This right to information shall also exist,","subject to the conditions set forth in","sentence 1, against the competent","authorities of the Member States which","are responsible for the surveillance of the","respective medical device, as well as","against any notified body that issued a","certificate pursuant to Article 45 or was","otherwise involved in the conformity","assessment procedure of the medical","device in question."],"old":["9. Manufacturers shall, in response to a","reasoned request from a competent","authority, provide it with all the","information and documentation necessary","to demonstrate the conformity of the","device, in an official Union language","which can be easily understood by that","authority. They shall cooperate with that","authority, at its request, on any corrective","action taken to eliminate the risks posed by","devices which they have placed on the","market or put into service.",""],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"155","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Christofer Fjellner, Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-272","justification":" The proposal counteracts with the basic principles of the CE marking of products, in which\n the manufacturer is responsible for ensuring that the product meets the applicable\n requirements and is properly CE marked. Article 42 introduce a review process in which\n agencies should examine products in the highest risk category, Class D, before they are CE\n marked and placed on the market. This form of pre-approval shifts responsibility from the\n manufacturer of the product to the authorities. A pre-approval system for in vitro medical\n devices will also increase the administrative burden for manufacturers, notified bodies,\n authorities and the Commission, without ensuring an actual increase in the safety for\n patients.","location":[["Proposal for a regulation","Article 42"]],"meps":[28126,96664],"meta":{"created":"2019-07-03T05:26:42"},"new":["deleted"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"272","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andr\u00e9s Perell\u00f3 Rodr\u00edguez","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-156","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 9"]],"meps":[96989],"meta":{"created":"2019-07-03T05:26:42"},"new":["9. Manufacturers shall, in response to a","reasoned request from a competent","authority or medical association or","institution, provide it with all the","information and documentation necessary","to demonstrate the conformity of the","device, in an official Union language","which can be easily understood by the","applicant. They shall cooperate with the","competent authority, at its request, on any","corrective action taken to eliminate the","risks posed by devices which they have","placed on the market or put into service."],"old":["9. Manufacturers shall, in response to a","reasoned request from a competent","authority, provide it with all the","information and documentation necessary","to demonstrate the conformity of the","device, in an official Union language","which can be easily understood by that","authority. They shall cooperate with that","authority, at its request, on any corrective","action taken to eliminate the risks posed by","devices which they have placed on the","market or put into service.","",""],"orig_lang":"es","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"156","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-273","location":[[" Proposal for a regulation","Article 42 \u2013 paragraph 1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:42"},"new":["1. Notified bodies shall notify the","Commission of applications for conformity","assessments for devices classified as class","D and for devices classified as class C","which fulfil the definition of novelty set","out in Article 2(12a), with the exception of","applications to supplement or renew","existing certificates. The notification shall","be accompanied by the draft instructions","for use referred to in Section 17.3 of Annex","I and the draft summary of safety and","performance referred to in Article 24. In its","notification the notified body shall indicate","the estimated date by which the conformity","assessment is to be completed. The","Commission shall immediately transmit the","notification and the accompanying","documents to the MDCG."],"old":["1. Notified bodies shall notify the","Commission of applications for conformity","assessments for devices classified as class","D, with the exception of applications to","supplement or renew existing certificates.","The notification shall be accompanied by","the draft instructions for use referred to in","Section 17.3 of Annex I and the draft","summary of safety and performance","referred to in Article 24. In its notification","the notified body shall indicate the","estimated date by which the conformity","assessment is to be completed. The","Commission shall immediately transmit the","notification and the accompanying","documents to the MDCG."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"273","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Jolanta Emilia Hibner","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-157","justification":" Obecnie stosowana jest koncepcja, \u015ce za wyr\u00f3b odpowiada wytw\u00f3rca. W przypadku wytw\u00f3rcy\n maj\u0105cego swoj\u0105 siedzib\u0119 w pa\u0144stwie trzecim, dalej jest on odpowiadzialny za wyr\u00f3b, bo\n autoryzowany przedstawiciel zajmuje si\u0119 tylko przekazywaniem informacji wytw\u00f3rcy. W tej\n sytuacji bardzo ci\u0119\u015cko prowadzi si\u0119 post\u0119powania wyja\u015bniaj\u0105ce, nie m\u00f3wi\u0105c ju\u015c o\n ewentualnych roszczeniach europejczyk\u00f3w za ewentualne szkody wyrz\u0105dzone przez wyroby.\n Brak podmiotu odpowiedzialnego za wyr\u00f3b wprowadzony do obrotu na rynku europejskim\n sprawia, \u015ce osoby kt\u00f3re ucierpia\u0142y w skutek wadliwego wyrobu, nie mog\u0105 dochodzi\u0107\n naprawienia szkody.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 10 a (new)"]],"meps":[96753],"meta":{"created":"2019-07-03T05:26:42"},"new":["10a. The manufacturer of the product","shall be responsible for the product, for","carrying out a conformity assessment on","the product before it is placed on the","market, and for placing the product on","the market. If the manufacturer is neither","resident nor based in a Member State, this","responsibility shall be borne by the","authorised representative for that product.","Where the manufacturer has not","designated an authorised representative,","or where the manufacturer or authorised","representative is not responsible for","placing the product on the market,","responsibility shall be borne by the entity","that placed the product on the market."],"orig_lang":"pl","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"157","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-274","location":[["Proposal for a regulation","Article 43 \u2013 paragraph 1"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:42"},"new":["1. The certificates issued by the notified","bodies in accordance with Annexes VIII,","IX and X shall be in an official Union","language acceptable to the notified body.","The minimum content of the certificates is","set out in Annex XI."],"old":["1. The certificates issued by the notified","bodies in accordance with Annexes VIII,","IX and X shall be in an official Union","language determined by the Member State","in which the notified body is established","or otherwise in an official Union language","acceptable to the notified body. The","minimum content of the certificates is set","out in Annex XI."],"orig_lang":"cs","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"274","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Andr\u00e9s Perell\u00f3 Rodr\u00edguez","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-158","justification":"Recent incidents involving fraudulent breast implants, in which patients have had to undergo\ncorrective surgery and other expensive treatments to monitor or diagnose their condition,\nhave highlighted the need for a legal clause requiring manufacturers to have insurance to\ncover damages to patients and the costs incurred by the health service.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 10 a (new)"]],"meps":[96989],"meta":{"created":"2019-07-03T05:26:42"},"new":["10a. Manufacturers of medical devices","must be covered by an insurance policy or","equivalent financial guarantee to meet","claims for health damage arising from","unsafe medical devices.","Manufacturers shall bear the cost to the","health system of treatment, operations","and diagnostic procedures practiced on","patients as a result of defects in or","malfunctioning of health devices detected","by the health authorities or the","manufacturers themselves.","They shall also bear the cost of","withdrawing, repairing or replacing the","products involved in these situations."],"orig_lang":"es","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"158","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-159","justification":" Recent incidents involving fraudulent breast implants, in which patients have had to undergo\n corrective surgery and other expensive treatments to monitor or diagnose their condition,\n have highlighted the need for a legal clause requiring manufacturers to have insurance to\n cover damages to patients and the costs incurred by the health service.","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 10 a (new)"]],"meps":[4319,4326],"meta":{"created":"2019-07-03T05:26:43"},"new":["10a. Manufacturers of medical devices","must be covered by an insurance policy or","equivalent financial guarantee to meet","claims for health damage arising from","unsafe medical devices."],"orig_lang":"es","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"159","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-275","location":[["Proposal for a regulation","Article 44 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:42"},"new":["1. Where a manufacturer decides to","terminate his contract with a notified body","and enters into a contract with another","notified body in respect of the conformity","assessment of the same device, it shall","inform its national authority responsible","for the notified bodies of this change. The","modalities of the change of notified body","shall be clearly defined in an agreement","between the manufacturer, the outgoing","notified body and the incoming notified","body. This agreement shall address at least","the following aspects:"],"old":["1. In cases where a manufacturer","terminates his contract with a notified","body and enters into a contract with","another notified body in respect of the","conformity assessment of the same device,","the modalities of the change of notified","body shall be clearly defined in an","agreement between the manufacturer, the","outgoing notified body and the incoming","notified body. This agreement shall address","at least the following aspects:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"275","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Pilar Ayuso, Cristina Guti\u00e9rrez-Cortines","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-160","justification":" Recent incidents involving fraudulent breast implants, in which patients have had to undergo\n corrective surgery and other expensive treatments to monitor or diagnose their condition,\n have highlighted the need for a legal clause requiring manufacturers to have insurance to\n cover damages to patients and the costs incurred by the health service.","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 10 b (new)"]],"meps":[4319,4326],"meta":{"created":"2019-07-03T05:26:43"},"new":["10b. Manufacturers shall bear the cost to","the health system of treatment, operations","and diagnostic procedures practiced on","patients as a result of defects in or","malfunctioning of health devices detected","by the health authorities or the","manufacturers themselves.","They shall also bear the cost of","withdrawing, repairing or replacing the","products involved in these situations."],"orig_lang":"es","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"160","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Jolanta Emilia Hibner","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-276","justification":" Art. 45 ust. 3 wskazuje, \u015ce Komisja mo\u015ce rozszerzy\u0107 na ca\u0142y obszar EU decyzj\u0119 pa\u0144stwa\n cz\u0142onkowskiego, kt\u00f3re wyrazi\u0142o zgod\u0119 na wprowadzenie na swoim terytorium wyrobu nie\n spe\u0142niaj\u0105cego wymaga\u0144 okre\u015blonych w rozporz\u0105dzeniu. Jest to kwestia \u015bci\u015ble polityczna,\n bowiem pa\u0144stwo cz\u0142onkowskie jest odpowiedzialne za bezpiecze\u0144stwo swoich obywateli i\n je\u015celi w innym kraju specjalnie powo\u0142ane do tego celu organy uznaj\u0105, \u015ce b\u0119d\u0105 tolerowa\u0142y\n ryzyko stosowania takich wyrob\u00f3w i wydania zezwolenia, aby na ich terytorium by\u0142y obecne\n wyroby nie spe\u0142niaj\u0105ce wymaga\u0144, to ponosz\u0105 ryzyko na w\u0142asn\u0105 odpowiedzialno\u015b\u0107. Z drugiej\n strony, je\u015celi kt\u00f3rykolwiek kraj Wsp\u00f3lnoty dowie si\u0119, \u015ce inne pa\u0144stwo cz\u0142onkowskie wyda\u0142o\n tak\u0105 decyzj\u0119, to mo\u015ce samodzielnie wyda\u0107 decyzj\u0119 podobn\u0105 i nie musi to by\u0107 decyzja Komisji\n Europejskiej. Przedmiotowy przepis narusza zasad\u0119 propocjonalno\u015bci i subsydiarno\u015bci.\n Wystarczaj\u0105ce dla osi\u0105gni\u0119cia celu regulacji s\u0105 tu dzia\u0142ania na poziomie pa\u0144stw\n cz\u0142onkowskich.","location":[[" Proposal for a regulation","Article 45 \u2013 paragraph 3"]],"meps":[96753],"meta":{"created":"2019-07-03T05:26:42"},"new":["deleted"],"old":["3. Upon request by a Member State and","where this is in the interest of public","health or patient safety in more than one","Member State, the Commission may, by","means of implementing acts, extend for a","determined period of time the validity of","an authorisation granted by a Member","State in accordance with paragraph 1 to","the territory of the Union and set the","conditions under which the device may be","placed on the market or put into service.","Those implementing acts shall be adopted","in accordance with the examination","procedure referred to in Article 84(3).","On duly justified imperative grounds of","urgency relating to the health and safety","of humans, the Commission shall adopt","immediately applicable implementing acts","in accordance with the procedure referred","to in Article 84(4)."],"orig_lang":"pl","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"276","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-277","location":[["Proposal for a regulation","Chapter 6 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["Chapter VI Chapter V","Clinical evidence Clinical evidence"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"277","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-161","justification":"Liability insurance with sufficient minimum coverage would ensure that the risk of damage as\nwell as the risk of the manufacturer\u2019s insolvency is averted from the injured patients and the\npayers liable for the cost of treatment.","location":[[" Proposal for a regulation","Article 8 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:43"},"new":["Article 8 a","To ensure that patients harmed will be","compensated for any damages and to","avert manufacturer\u2019s insolvency,","manufacturers shall be obliged to take out","liability insurance with sufficient","minimum coverage."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"161","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-278","location":[["Proposal for a regulation","Article 48 \u2013 paragraph 1 \u2013 point b"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["(b) to verify the clinical safety and","efficacy of the device, including the","intended benefits to the patient, when used","for the intended purpose, in the target","population and in accordance with the","instructions of use;"],"old":["(b) to verify that devices achieve the","intended benefits to the patient as specified","by the manufacturer;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"278","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-162","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["2. The designation shall be valid only when","accepted in writing by the authorised","representative."],"old":["2. The designation shall be valid only when","accepted in writing by the authorised","representative and shall be effective at","least for all devices of the same generic","device group."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"162","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-279","location":[["Proposal for a regulation","Article 48 \u2013 paragraph 4"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["4. All clinical performance studies shall be","designed and conducted in a way that the","rights, safety and well-being of the subjects","participating in such clinical performance","studies are protected, in accordance with","Article 48 a (3), and that the clinical data","generated in the clinical performance study","are going to be reliable and robust."],"old":["4. All clinical performance studies shall be","designed and conducted in a way that the","rights, safety and well-being of the subjects","participating in such clinical performance","studies are protected and that the clinical","data generated in the clinical performance","study are going to be reliable and robust."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"279","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-163","location":[["Proposal for a regulation","Article 9 \u2013 paragraph 3 \u2013 subparagraph 2 \u2013 point a"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["(a) keep a summary of the technical","documentation, the EU declaration of","conformity and, if applicable, a copy of the","relevant certificate, including any","supplement, issued in accordance with","Article 43 at the disposal of competent","authorities for the period referred to in","Article 8(4);"],"old":["(a) keep the technical documentation, the","EU declaration of conformity and, if","applicable, a copy of the relevant","certificate, including any supplement,","issued in accordance with Article 43 at the","disposal of competent authorities for the","period referred to in Article 8(4);"],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"163","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-280","location":[[" Proposal for a regulation","Article 48 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["Article 48 a","Involvement of Ethics Committee","1. Authorisation to conduct a clinical","performance study may only be granted if","an independent ethics committee has","previously submitted a positive evaluation","of that performance study.","2. The statement of the Ethics Committee","shall cover in particular the medical","justification, the consent of the test","subjects participating in the clinical","performance study following the provision","of full information about the clinical","performance study and the suitability of","the investigators and investigation","facilities.","3. The Ethics Committee shall ensure that","the rights, safety and well-being of","subjects participating in a clinical","performance study are protected.","4. It shall be independent of the","researcher, independent of the sponsor,","and free of any other undue influence. It","shall act in accordance with the laws and","regulations of the country or countries in","which the research is to be conducted and","must abide by all relevant international","norms and standards.","5. The Ethics Committee shall consist of a","clearly defined number of members and","substitutes which include healthcare","professionals, laypersons and at least one","well-experienced, knowledgeable patient","or patient representative, who collectively","possess the relevant qualifications and","experience to be able to review and","evaluate the scientific, medical and","ethical aspects of the proposed clinical","performance study.","6. Member States shall take the necessary","measures to establish Ethics Committees","where such committees do not exist, and","to facilitate their work.","Members States shall publish the number,","the names and the professions of the","members and substitutes of the Ethics","Committees and inform the Commission","about the composition of the Ethics","Committees and the date on which they","become operational."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"280","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-164","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["(a) they shall verify that the conformity","assessment procedure has been carried out","by the manufacturer;"],"old":["(a) that the appropriate conformity","assessment procedure has been carried out","by the manufacturer;"],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"164","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-281","location":[["Proposal for a regulation","Article 49 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["The sponsor of a clinical performance","study shall submit an application to the","Member State(s) in which the study is to be","conducted accompanied by the","documentation referred to in Annex XIII.","Within ten days after receipt of the","application, the Member State concerned","shall notify the sponsor whether the","clinical performance study falls within the","scope of this Regulation and whether the","application is complete."],"old":["The sponsor of a clinical performance","study shall submit an application to the","Member State(s) in which the study is to be","conducted accompanied by the","documentation referred to in Annex XIII.","Within six days after receipt of the","application, the Member State concerned","shall notify the sponsor whether the","clinical performance study falls within the","scope of this Regulation and whether the","application is complete."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"281","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-165","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["Where an importer considers that a device","is not in conformity with the requirements","of this Regulation or presents a risk, the","importer shall inform the manufacturer and","his authorised representative to that effect,","as well as the competent authority of the","Member State, and shall only place the","device on the market with the agreement","of the manufacturer."],"old":["Where an importer considers or has","reason to believe that a device is not in","conformity with the requirements of this","Regulation, he shall not place the device","on the market until it has been brought","into conformity. Where the device presents","a risk, the importer shall inform the","manufacturer and his authorised","","representative to that effect, as well as the","competent authority of the Member State","in which he is established."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"165","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas","changes":{},"committee":["ENVI"],"compromise":[" Ulmer, Renate Sommer, Miroslav Mikol\u00e1\u0161ik"],"date":"2013-05-13T00:00:00","id":"PE510.755-282","justification":" The decision of the reporting member state is binding for the others. It could happen that a\n reporting member state supports a clinical performance study while the authorities and ethic\n committees of the majority of the concerned member states not. Even if the authorities and\n ethic committees work together to find agreement, there must a solution to resolve conflicts.\n The Commission is accountable to scrutiny by the EP and Council, so is better authorised to\n take such a decision then the reporting member state.","location":[[" Proposal for a regulation","Article 49 \u2013 paragraph 2 \u2013 subparagraph 1 a (new)"]],"meps":[1927,28161,21818,96914,96664,114279],"meta":{"created":"2019-07-03T05:26:43"},"new":["In case of more than one Member State","concerned, where there is a disagreement","on whether the clinical performance study","should be approved, the member states","concerned shall make an attempt to agree","on a conclusion. If no conclusion is","found, the European Commission takes a","decision after hearing the member states","concerned, and if appropriate taking","advice from EMA."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"282","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-283","location":[[" Proposal for a regulation","Article 49 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["Where the Member State finds that the","clinical performance study applied for does","not fall within the scope of this Regulation","or that the application is not complete, it","shall inform the sponsor thereof and shall","set a maximum of ten days for the sponsor","to comment or to complete the application."],"old":["Where the Member State finds that the","clinical performance study applied for does","not fall within the scope of this Regulation","or that the application is not complete, it","shall inform the sponsor thereof and shall","set a maximum of six days for the sponsor","to comment or to complete the application."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"283","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-166","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 3"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["3. Importers shall ensure that their device","is registered in the electronic system in","accordance with Article 23(2)."],"old":["3. Importers shall indicate their name,","registered trade name or registered trade","mark and the address of their registered","place of business at which they can be","contacted and their location can be","established on the device or on its","packaging or in a document","accompanying the device. They shall","ensure that any additional label does not","obscure any information on the label","provided by the manufacturer."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"166","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-167","location":[["Proposal for a regulation","Article 11 \u2013 paragraph 5"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["5. When deemed appropriate with regard","to the risks presented by a device,","importers shall investigate and keep a","register of complaints, of non-compliant","products and of cases in which a product","is withdrawn from the market or from","circulation, and shall notify the","manufacturer, the authorised","representative and the distributors of this."],"old":["5. Importers shall ensure that, while a","device is under their responsibility,","storage or transport conditions do not","jeopardise its compliance with the general","safety and performance requirements set","out in Annex I.",""],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"167","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-284","location":[["Proposal for a regulation","Article 49 \u2013 paragraph 3 \u2013 subparagraph 3"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["Where the Member State has not notified","the sponsor according to paragraph 2","within five days following receipt of the","comments or of the completed application,","the clinical performance study shall be","considered as falling within the scope of","this Regulation and the application shall be","considered complete."],"old":["Where the Member State has not notified","the sponsor according to paragraph 2","within three days following receipt of the","comments or of the completed application,","the clinical performance study shall be","considered as falling within the scope of","this Regulation and the application shall be","considered complete."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"284","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-168","location":[[" Proposal for a regulation","Article 11 \u2013 paragraph 6"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["6. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","inform the manufacturer and the","authorised representative. Where the","device presents a risk, they shall also","immediately inform the competent","authorities of the Member States in which","they made the device available and, if","applicable, the notified body that issued a","certificate in accordance with Article 43","for the device in question, giving details,","in particular, of the non-compliance and","of any corrective action taken."],"old":["6. When deemed appropriate with regard","to the risks presented by a device,","importers shall, in order to protect the","health and safety of patients and users,","carry out sample testing of marketed","products, investigate complaints and keep","a register of complaints, of non-","conforming products and of product","recalls and withdrawals, and shall keep","the manufacturer, authorised","representative and distributors informed","of such monitoring."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"168","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-169","justification":"Within the supply chain, distributors are responsible for product safety. Outside it,\nresponsibility for product safety and for completeness of documentation lies with the\nmanufacturer or importer.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:43"},"new":["Before making a device available on the","market for the first time, distributors shall","verify that the following requirements are","met:"],"old":["Before making a device available on the","market distributors shall verify that the","following requirements are met:"],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"169","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-285","location":[["Proposal for a regulation","Article 49 \u2013 paragraph 5 \u2013 point c"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["(c) after the expiry of 60 days after the","validation date referred to in paragraph 4,","unless the Member State concerned has","notified the sponsor within that period of","its refusal based on considerations of","public health, patient safety or public","policy."],"old":["(c) after the expiry of 35 days after the","validation date referred to in paragraph 4,","unless the Member State concerned has","notified the sponsor within that period of","its refusal based on considerations of","public health, patient safety or public","policy."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"285","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-170","justification":"Within the supply chain, distributors are responsible for product safety. Outside it,\nresponsibility for product safety and for completeness of documentation lies with the\nmanufacturer or importer.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:43"},"new":["(b) in the absence of a declaration of","conformity by the manufacturer or","importer, the product is accompanied by","the information to be supplied by the","manufacturer in accordance with Article","8(7);"],"old":["(b) the product is accompanied by the","information to be supplied by the","manufacturer in accordance with Article","8(7);"],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"170","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-286","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 1 \u2013 point g a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["(g a) the methodology to be used, the","number of subjects involved and the","intended result of the study."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"286","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-171","justification":" Within the supply chain, distributors are responsible for product safety. Outside it,\n responsibility for product safety and for completeness of documentation lies with the\n manufacturer or importer.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:43"},"new":["(c) the manufacturer and, where applicable,","the importer have complied with the","requirements set out in Article 11(3)."],"old":["(c) the manufacturer and, where applicable,","the importer have complied with the","requirements set out in Article 22 and","Article 11(3) respectively."],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"171","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-287","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 2 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:43"},"new":["2a. Upon completion of the clinical","performance study, the sponsor shall","enter in the electronic system referred to","in Article 51 a summary of its results","drawn up in a way that is easy for a lay","person to understand."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"287","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-172","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:43"},"new":["Where a distributor considers that a device","is not in conformity with the requirements","of this Regulation or presents a risk, the","distributor shall inform the manufacturer","and his authorised representative to that","effect, as well as the competent authority","of the Member State, and shall only place","the device on the market with the","agreement of the manufacturer."],"old":["Where a distributor considers or has","reason to believe that a device is not in","conformity with the requirements of this","Regulation, he shall not make the device","available on the market until it has been","brought into conformity. Where the device","presents a risk, the distributor shall inform","the manufacturer and, where applicable,","his authorised representative and the","importer to that effect, as well as the","competent authority of the Member State","in which he is established."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"172","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-288","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 3 \u2013 introductory part"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:43"},"new":["3. The information shall be fully accessible","to the public, through the electronic system","referred to in Article 51."],"old":["3. The information shall be accessible to","the public, through the electronic system","referred to in Article 51, unless, for all or","parts of that information, confidentiality","of the information is justified on any of","the following grounds:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"288","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-173","justification":"A distinction should be made between the various participants in the supply chain.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 4"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:44"},"new":["4. Distributors who consider or have reason","to believe that a device which they have","made available on the market is not in","conformity with this Regulation shall","immediately inform the manufacturer and,","where applicable, his authorised","representative and the importer and, within","their respective area of activity, make sure","that the necessary corrective action to bring","that device into conformity, withdraw or","recall it, if appropriate, is taken. Where the","device presents a risk, they shall also","immediately inform the competent","authorities of the Member States in which","they made the device available, giving","details, in particular, of the non-compliance","and of any corrective action taken."],"old":["4. Distributors who consider or have reason","to believe that a device which they have","made available on the market is not in","conformity with this Regulation shall","immediately inform the manufacturer and,","where applicable, his authorised","representative and the importer and make","","","sure that the necessary corrective action to","bring that device into conformity,","withdraw or recall it, if appropriate, is","taken. Where the device presents a risk,","they shall also immediately inform the","competent authorities of the Member States","in which they made the device available,","giving details, in particular, of the non-","compliance and of any corrective action","taken."],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"173","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-289","justification":"The protection of personal data is already ensured in point number 4 stating that \"No\npersonal data of subjects participating in the clinical performance study shall be accessible to\nthe public.\"","location":[["Proposal for a regulation","Article 50 \u2013 paragraph 3 \u2013 point a"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:43"},"new":["deleted"],"old":["(a) protection of personal data in","accordance with Regulation (EC) No","45/2001,"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"289","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-174","justification":" The proposal does not distinguish between the different roles and responsibilities of the\n stakeholders involved in the supply chain of in vitro diagnostic medical devices. All\n distributors have the same obligations, some of which are in practice unworkable. This\n proposal would link the obligation to the activity carried out by the distributor. The\n amendment adopts the approach in Article 19(2) of Regulation 18/2002 on Food Safety.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 4"]],"meps":[1927,113487,28161,21818,96914,96664,28221,39916,4282,28178],"meta":{"created":"2019-07-03T05:26:44"},"new":["4. Distributors who consider or have reason","to believe that a device which they have","made available on the market is not in","conformity with this Regulation shall","immediately inform the manufacturer and,","where applicable, his authorised","representative and the importer and make","sure that, within the limits of its respective","activities, the necessary corrective action to","bring that device into conformity,","withdraw or recall it, if appropriate, is","taken. 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Where the device presents a risk,","they shall also immediately inform the","competent authorities of the Member States","in which they made the device available,","giving details, in particular, of the non-","compliance and of any corrective action","taken."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"174","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-290","justification":"For effective transparency and to ensure access for independent researchers to do\nrandomised performance studies and meta-analysis, the database should be publicly\naccessible.","location":[["Proposal for a regulation","Article 50 \u2013 paragraph 3 \u2013 point b"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:43"},"new":["deleted"],"old":["(b) protection of commercially sensitive","information,"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"290","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-175","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 6"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:44"},"new":["6. Distributors shall cooperate with","competent national authorities, at their","request, on any action taken to eliminate","the risks posed by devices which they have","made available on the market."],"old":["6. Distributors shall, in response to a","request from a competent authority,","provide it with all the information and","documentation necessary to demonstrate","the conformity of a device. This obligation","shall be considered fulfilled when the","authorised representative for the device in","question, where applicable, provides the","required information. Distributors shall","cooperate with competent national","authorities, at their request, on any action","taken to eliminate the risks posed by","devices which they have made available on","the market."],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"175","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-291","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 3 \u2013 point b"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:43"},"new":["deleted"],"old":["(b) protection of commercially sensitive","information,"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"291","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-176","justification":"It must be ensured that the diploma or certificate of the qualified person is on a sufficiently\nhigh level. Furthermore two years of industry experience does not guarantee a sufficient level\nof \"expert knowledge\".","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 point a"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) a diploma, certificate or other evidence","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study at university","level, in natural sciences, medicine,","pharmacy, engineering or another relevant","discipline, and at least five years of","professional experience in regulatory","affairs or in quality management systems","relating to in vitro diagnostic medical","devices;"],"old":["(a) a diploma, certificate or other evidence","","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study, in natural","sciences, medicine, pharmacy, engineering","or another relevant discipline, and at least","two years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"176","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Paolo Bartolozzi, Anne Delvaux, Thomas Ulmer, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-177","justification":"The institution of a qualified person doesn\u2019t exist in the current directive. It imposes new\n\n\n burden for companies, especially for SMEs. This is necessary but we should not go further\n than the situation in the more advanced member states.","location":[["Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 point a"]],"meps":[1927,21818,96914,28221,4282,28178],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) a diploma, certificate or other evidence","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study, in natural","sciences, medicine, pharmacy, engineering","or another relevant discipline;"],"old":["(a) a diploma, certificate or other evidence","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study, in natural","sciences, medicine, pharmacy, engineering","or another relevant discipline, and at least","two years of professional experience in","regulatory affairs or in quality","management systems relating to in vitro","diagnostic medical devices;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"177","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-178","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 point b"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:44"},"new":["(b) 10 years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices as well as a proven in-","depth knowledge of both the therapeutic","area and the product type(s) concerned."],"old":["(b) five years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"178","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-292","justification":" The effective supervision of performance studies should not be clouded but transparent and\n subject to public scrutiny.","location":[[" Proposal for a regulation","Article 50 \u2013 paragraph 3 \u2013 point c"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:44"},"new":["deleted"],"old":["(c) effective supervision of the conduct of","the clinical performance study by the","Member State(s) concerned."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"292","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese, Paolo Bartolozzi, Anne Delvaux, Thomas Ulmer, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-179","justification":" The institution of a qualified person doesn\u2019t exist in the current directive. It imposes new\n burden for companies, especially for SMEs. This is necessary but we should not go further\n than the situation in the more advanced member states.","location":[[" Proposal for a regulation","Article 13 \u2013 paragraph 1 \u2013 point b"]],"meps":[1927,21818,96914,28221,4282,28178],"meta":{"created":"2019-07-03T05:26:44"},"new":["(b) two years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices."],"old":["(b) five years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"179","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-293","justification":"The database should be set up with the intent of providing both citizens, doctors and\nindependent researchers with information that enables them to make informed decisions\nabout the use of in-vitro devices.","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:44"},"new":["1. The Commission shall, in collaboration","with the Member States, set up and manage","an electronic system on interventional","clinical performance studies and other","clinical performance studies involving","risks for the subjects of the studies. The","existence of this database will allow the","public to be able to search for specific","performance studies and citizens and","professionals to make informed decisions","about in-vitro devices. To ensure this, the","electronic system will help to create the","single identification numbers for such","clinical performance studies referred to in","Article 49(1) and to collate and process the","following information:"],"old":["1. The Commission shall, in collaboration","with the Member States, set up and manage","an electronic system on interventional","clinical performance studies and other","clinical performance studies involving","risks for the subjects of the studies to","create the single identification numbers for","such clinical performance studies referred","to in Article 49(1) and to collate and","process the following information:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"293","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-180","justification":"It must be ensured that the diploma or certificate of the qualified person is on a sufficiently\nhigh level. Furthermore two years of industry experience does not guarantee a sufficient level\nof \"expert knowledge\".","location":[["Proposal for a regulation","Article 13 \u2013 paragraph 4 \u2013 point a"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) a diploma, certificate or other evidence","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study at university","level, in law, natural sciences, medicine,","pharmacy, engineering or another relevant","discipline, and at least five years of","professional experience in regulatory","affairs or in quality management systems","relating to in vitro diagnostic medical","devices;"],"old":["(a) a diploma, certificate or other evidence","of formal qualification awarded on","completion of a university degree or of an","equivalent course of study, in law, natural","sciences, medicine, pharmacy, engineering","or another relevant discipline, and at least","two years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"180","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-181","location":[["Proposal for a regulation","Article 13 \u2013 paragraph 4 \u2013 point b"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:44"},"new":["(b) ten years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices as well as a proven in-","depth knowledge of both the therapeutic","area and the product(s) concerned.."],"old":["(b) five years of professional experience in","regulatory affairs or in quality management","systems relating to in vitro diagnostic","medical devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"181","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-294","justification":"It should be clarified that Clinical Performance Study Reports shall be part of the information\n\n available to the public and healthcare professionals. These amendments ensure that a degree\n of coherency can be found with the likely outcome of the Clinical Trials negotiations.","location":[["Proposal for a regulation","Article 51 \u2013 paragraph 1 \u2013 point c a (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:44"},"new":["(c a) the clinical performance study","reports submitted by sponsors in Article","56(5);"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"294","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-182","justification":" Manufacturers market their products in the individual Member States through subsidiaries or\n distributors. On behalf of the manufacturer, the latter also perform activities as referred to in\n Article 14(2), acting on instructions from, and coordinating their work with, the\n manufacturer. In this case there is no justification for additional requirements regarding\n characterisation of the activity or regarding procedural matters and communications with the\n manufacturer and the authorities, and such requirements would result in a good deal of\n expense.","location":[[" Proposal for a regulation","Article 14 \u2013 paragraph 4 a (new)"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:44"},"new":["4a. Distributors or affiliates who carry out","\u2013 on behalf of the manufacturer \u2013 one or","several of the activities mentioned under","paragraph 2 points (a) and (b) \u2013 are","exempted from additional requirements","under points (3) and (4)."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"182","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-295","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [\u2026] of Regulation","(EU) No [Ref. of future Regulation on","clinical trials]. With the exception of the","information referred to in Article 50, the","information collated and processed in the","electronic system shall be accessible to the","Member States and to the Commission.","The Commission shall also ensure that","healthcare professionals have access to","the electronic system."],"old":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [\u2026] of Regulation","(EU) No [Ref. of future Regulation on","clinical trials]. With the exception of the","information referred to in Article 50, the","information collated and processed in the","electronic system shall be accessible only","to the Member States and to the","Commission."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"295","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-183","justification":"Granting of the CE-marking by notified bodies must be justified in a summary explaining the\nreason for granting access to the market.","location":[[" Proposal for a regulation","Article 16 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:44"},"new":["Article 16a","The granting of the CE-marking is","followed by the publication of a summary","describing the basis for granting the CE-","marking."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"183","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-184","location":[["Proposal for a regulation","Chapter 3 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["Chapter III Chapter VII","Identification and traceability of devices,","registration of devices and of economic","operators, summary of safety and","performance, European databank on","medical devices"],"old":["","Identification and traceability of devices,","registration of devices and of economic","operators, summary of safety and","performance, European databank on","medical devices"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"184","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-296","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 2"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:44"},"new":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [\u2026] of Regulation","(EU) No [Ref. of future Regulation on","clinical trials]. The information collated","and processed in the electronic system","shall be accessible to the Member States, to","the Commission, and the Commission","shall also ensure that healthcare","professionals and patients have access to","the electronic system"],"old":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [\u2026] of Regulation","","(EU) No [Ref. of future Regulation on","clinical trials]. With the exception of the","information referred to in Article 50, the","information collated and processed in the","electronic system shall be accessible only","to the Member States and to the","Commission."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"296","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Milan Cabrnoch","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-185","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[28324],"meta":{"created":"2019-07-03T05:26:44"},"new":["For devices, other than devices for","performance evaluation, economic","operators shall be able to identify the","following, for a period of 10 years:"],"old":["For devices, other than devices for","performance evaluation, economic","operators shall be able to identify the","following, for the period referred to in","Article 8(4):"],"orig_lang":"cs","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"185","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-297","location":[["Proposal for a regulation","Article 51 \u2013 paragraph 2 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["2a. Upon a reasoned request, all","information on a specific in vitro","diagnostic medical device available in the","electronic system shall be made accessible","to the party requesting it, save where the","confidentiality of all or parts of the","information is justified on any of the","following grounds:","(a) protection of personal data in","accordance with Regulation (EC) No","45/2001;","(b) protection of commercially sensitive","information;","(c) effective supervision of the conduct of","the clinical performance study by the","Member State(s) concerned."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"297","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-186","location":[["Proposal for a regulation","Article 21 \u2013 paragraph 1 \u2013 point c"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:44"},"new":["(c) any organization or healthcare","professional to whom they have supplied a","device."],"old":["(c) any health institution or healthcare","professional to whom they have supplied a","device."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"186","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-298","location":[["Proposal for a regulation","Article 54 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["1. Where a Member State has refused,","suspended or terminated a clinical","performance study, or has called for a","substantial modification or temporary halt","of a clinical performance study, or has","been notified by the sponsor of the early","termination of a clinical performance study","on safety or efficacy grounds, that Member","State shall communicate its decision and","the grounds for that decision to all","Member States and the Commission by","means of the electronic system referred to","in Article 51."],"old":["1. Where a Member State has refused,","suspended or terminated a clinical","performance study, or has called for a","substantial modification or temporary halt","of a clinical performance study, or has","been notified by the sponsor of the early","termination of a clinical performance study","on safety grounds, that Member State shall","communicate its decision and the grounds","therefor to all Member States and the","Commission by means of the electronic","system referred to in Article 51."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"298","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-187","justification":" The UDI System is a vital component of the new Regulatory system, and providers of UDIs\n should ensure a greater degree of permanence to their role","location":[[" Proposal for a regulation","Article 22 \u2013 paragraph 2 \u2013 point e \u2013 point i"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:45"},"new":["(i) to operate its system for the assignment","of UDIs for the period to be determined in","the designation which shall at least be five","years after its designation;"],"old":["(i) to operate its system for the assignment","of UDIs for the period to be determined in","the designation which shall at least be","three years after its designation;"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"187","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-299","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["1. If the sponsor has temporarily halted a","clinical performance study on safety or","efficacy grounds, he shall inform the","Member States concerned within 15 days","of the temporary halt."],"old":["1. If the sponsor has temporarily halted a","clinical performance study on safety","grounds, he shall inform the Member","States concerned within 15 days of the","temporary halt."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"299","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber, Thomas Ulmer","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-188","justification":"So that the process runs smoothly, it is important that traceability systems be technically\ncompatible.","location":[[" Proposal for a regulation","Article 22 \u2013 paragraph 8 \u2013 point e a (new)"]],"meps":[28227,28221],"meta":{"created":"2019-07-03T05:26:45"},"new":["(ea) compatibility with medical device","identification systems already on the","market."],"orig_lang":"de","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"188","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-189","justification":"It is likely an electronic medicine authentication system will be out in place pursuant to\nFalsified Medicines Directive. It is important that the systems for in vitro medical devices and\nmedicines are compatible, otherwise this will bring a significant and possibly unmanageable\nburden for the agents of the supply chain working with both kinds of products.","location":[["Proposal for a regulation","Article 22 \u2013 paragraph 8 \u2013 point e a (new)"]],"meps":[1927,113487,28161,21818,96914,96664,28221,4282,28178],"meta":{"created":"2019-07-03T05:26:45"},"new":["(ea) the compatibility with other","traceability systems used by the","stakeholders involved with medical","devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"189","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-190","justification":" The principal role of the electronic system set up by the Commission is to ensure public\n insight through transparent access to information regarding the clinical validity and safe\n performance of the in-vitro devices.","location":[["Proposal for a regulation","Article 23 \u2013 paragraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:45"},"new":["1. The Commission, in collaboration with","the Member States, shall set up and","manage an electronic system to collate and","process information that is necessary and","proportionate to describe and identify the","device and to identify the manufacturer","and, where applicable, the authorised","representative and the importer, and to","ensure transparency and safe and","effective use by making available to users","current evidence concerning the clinical","validity and, where applicable, utility of","the device. The details regarding the","information to be submitted by the","economic operators are laid down in Part A","of Annex V."],"old":["1. The Commission, in collaboration with","the Member States, shall set up and","manage an electronic system to collate and","process information that is necessary and","proportionate to describe and identify the","device and to identify the manufacturer","and, where applicable, the authorised","representative and the importer. The details","","regarding the information to be submitted","by the economic operators are laid down in","Part A of Annex V."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"190","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-300","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["The sponsor shall notify each Member","State concerned of the end of a clinical","performance study in relation to that","Member State, providing a justification in","the event of early termination, so that all","Member States can inform sponsors","conducting similar clinical performance","studies at the same time within the Union","of the results of that clinical performance","study. That notification shall be made","within 15 days from the end of the clinical","performance study in relation to that","Member State."],"old":["The sponsor shall notify each Member","","State concerned of the end of a clinical","performance study in relation to that","Member State, providing a justification in","the event of early termination. That","notification shall be made within 15 days","from the end of the clinical performance","study in relation to that Member State."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"300","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-191","location":[[" Proposal for a regulation","Article 24 \u2013 paragraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:45"},"new":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a extensive report of safety","and performance. It shall be written in a","way that is clear to the intended user. The","draft of this extensive report shall be part","of the documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"old":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be written in a way","that is clear to the intended user. The draft","of this summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"191","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-301","location":[["Proposal for a regulation","Article 55 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["If the study is conducted in more than one","Member State, the sponsor shall notify all","Member States concerned of the overall","end of the clinical performance study.","Information on the reasons for the early","termination of the clinical performance","study shall also be provided to all Member","States, so that all Member States can","inform sponsors conducting similar","clinical performance studies at the same","time within the Union of the results of","that the clinical performance study. That","notification shall be made within 15 days","from the overall end of the clinical","performance study."],"old":["If the study is conducted in more than one","Member State, the sponsor shall notify all","Member States concerned of the overall","end of the clinical performance study. That","notification shall be made within 15 days","from the overall end of the clinical","performance study."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"301","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-192","location":[["Proposal for a regulation","Article 24 \u2013 paragraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:45"},"new":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be made publicly","available and written in a way that is clear","to the intended user. The draft of this","summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"old":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be written in a way","that is clear to the intended user. The draft","of this summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"192","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-302","justification":" While the Clinical Performance Study Report is a form of summary, it is important that\n manufacturers understand this Report will become part of the publicly accessible information.","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 3"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:44"},"new":["3. Within one year from the end of the","clinical performance study, the sponsor","shall submit to the Member States","concerned the results of the clinical","performance study in form of a clinical","performance study report referred to in","Section 2.3.3 of Part A of Annex XII.","Where, for scientific reasons, it is not","possible to submit the clinical performance","study report within one year, it shall be","submitted as soon as it is available. In this","case, the clinical performance study","protocol referred to in Section 2.3.2 of Part","A of Annex XII shall specify when the","results of the clinical performance study","are going to be submitted, together with an","explanation."],"old":["3. Within one year from the end of the","clinical performance study, the sponsor","shall submit to the Member States","concerned a summary of the results of the","clinical performance study in form of a","clinical performance study report referred","to in Section 2.3.3 of Part A of Annex XII.","Where, for scientific reasons, it is not","possible to submit the clinical performance","study report within one year, it shall be","submitted as soon as it is available. In this","case, the clinical performance study","protocol referred to in Section 2.3.2 of Part","A of Annex XII shall specify when the","results of the clinical performance study","are going to be submitted, together with an","explanation."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"302","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-193","justification":"In order to allow for full transparency regarding the quality of products and to demonstrate\ntheir safe usage, all relevant information concerning the safety, performance and incidents of\nin-vitro devices must be publicly available.","location":[["Proposal for a regulation","Article 25 \u2013 paragraph 1"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Commission shall develop and manage","the European databank on medical devices","(Eudamed) in accordance with the","conditions and modalities established by","Article 27 of Regulation (EU) [Ref. of","future Regulation on medical devices]and","ensure public access to it."],"old":["The Commission shall develop and manage","the European databank on medical devices","(Eudamed) in accordance with the","conditions and modalities established by","Article 27 of Regulation (EU) [Ref. of","future Regulation on medical devices]."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"193","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-303","location":[[" Proposal for a regulation","Article 56 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["2. In the single application, the sponsor","shall propose one of the Member States","concerned as coordinating Member State.","The reporting Member State shall be","chosen from among the Member States","concerned in which most of the subjects","participating in the clinical performance","study in question live. If that Member","State does not wish to be the coordinating","Member State, it shall agree, within six","days of submission of the single","application, with another Member State","concerned that the latter shall be the","coordinating Member State. If no other","Member State accepts to be the","coordinating Member State, the Member","State proposed by the sponsor shall be the","coordinating Member State. If another","Member State than the one proposed by the","sponsor becomes coordinating Member","State, the deadlines referred to in Article","49(2) shall start on the day following the","acceptance."],"old":["2. In the single application, the sponsor","shall propose one of the Member States","concerned as coordinating Member State.","If that Member State does not wish to be","the coordinating Member State, it shall","agree, within six days of submission of the","single application, with another Member","","","State concerned that the latter shall be the","coordinating Member State. If no other","Member State accepts to be the","coordinating Member State, the Member","State proposed by the sponsor shall be the","coordinating Member State. If another","Member State than the one proposed by the","sponsor becomes coordinating Member","State, the deadlines referred to in Article","49(2) shall start on the day following the","acceptance."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"303","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-194","justification":" The European Databank provides the main portal through which vital public health related\n information can be accessed. Information related to registered devices, economic operators,\n clinical investigations, vigilance data and market-surveillance activities should be available,\n for both the general public and for healthcare professionals.","location":[[" Proposal for a regulation","Article 25 \u2013 paragraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Commission shall develop and manage","the European databank on medical devices","(Eudamed) in accordance with the","conditions and modalities established by","Article 27 of Regulation (EU) [Ref. of","future Regulation on medical devices].","The Commission shall consult patients","groups and healthcare professionals when","developing the European Databank"],"old":["The Commission shall develop and","manage the European databank on medical","devices (Eudamed) in accordance with the","conditions and modalities established by","Article 27 of Regulation (EU) [Ref. of","future Regulation on medical devices]."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"194","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-304","location":[["Proposal for a regulation","Article 57 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) any adverse event that has a causal","relationship with the device for","performance evaluation, the comparator or","the study procedure or where such causal","relationship is reasonably possible;"],"old":["(a) a serious adverse event that has a","causal relationship with the device for","performance evaluation, the comparator or","the study procedure or where such causal","relationship is reasonably possible;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"304","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Christofer Fjellner, Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-195","justification":"Where a Community harmonization legislation provides that a body for conformity\nassessment shall be appointed for its implementation, transparent accreditation, as provided\nfor in Regulation (EC) No 765/2008, should be considered the preferred means of\ndemonstrating the technical competence of those bodies. However, national authorities may\nconsider that they possess the appropriate means of carrying out this evaluation themselves.\nIn such cases, in order to ensure the appropriate level of credibility of evaluations carried out\nby other national authorities, they should provide the Commission and the other Member\nStates with the necessary documentary evidence demonstrating the compliance of the\nconformity assessment bodies evaluated with the relevant regulatory requirements. A\ntransparent accreditation system would strengthen the principle of mutual recognition.","location":[[" Proposal for a regulation","Article 26 \u2013 paragraph 1 \u2013 subparagraph 2 (new)"]],"meps":[28126,96664],"meta":{"created":"2019-07-03T05:26:45"},"new":["Member States may decide that the","assessment and monitoring referred to in","the first subparagraph shall be carried out","by a national accreditation body within","the meaning of and in accordance with","Regulation (EC) No 765/2008."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"195","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-305","location":[["Proposal for a regulation","Chapter 7 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["Chapter VII Chapter VIII","Vigilance and market surveillance"],"old":["","Vigilance and market surveillance"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"305","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-196","location":[["Proposal for a regulation","Article 26 \u2013 paragraph 6 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["The national authority responsible for","notified bodies shall have a sufficient","number of permanent and competent","personnel \"in house\" for the proper","performance of its tasks. Compliance with","that requirement shall be assessed in the","peer-review referred to in paragraph 8.","In particular, the personnel of the","national authority responsible for","auditing the work of personnel of notified","bodies in charge of carrying out product","related reviews shall have proven","qualifications equivalent to those of the","personnel of the notified bodies as laid","down in point 3.2.5. of Annex VI.","Similarly, the personnel of the national","authority responsible for auditing the","work of personnel of notified bodies in","charge of carrying out audits of the","manufacturer\u2019s quality management","system shall have proven qualifications","equivalent to those of the personnel of the","notified bodies as laid down in point 3.2.6.","of Annex VI."],"old":["The national authority responsible for","notified bodies shall have a sufficient","number of competent personnel at its","disposal for the proper performance of its","tasks."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"196","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-306","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) any serious incident ,including date","and place of incident, in respect of devices","made available on the Union market;","where available, the manufacturer shall","include information on the patient or user","and healthcare professional involved in","the incident;"],"old":["(a) any serious incident in respect of","devices made available on the Union","market;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"306","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-197","location":[[" Proposal for a regulation","Article 26 \u2013 paragraph 6 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["Where a national authority is responsible","for the designation of notified bodies in the","field of products other than in vitro","diagnostic medical devices, the competent","authority for in vitro diagnostic medical","devices shall be consulted on all aspects","specifically related to such devices."],"old":["Without prejudice to Article 31(3), where","a national authority is responsible for the","designation of notified bodies in the field","of products other than in vitro diagnostic","medical devices, the competent authority","for in vitro diagnostic medical devices","shall be consulted on all aspects","specifically related to such devices."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"197","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-307","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:44"},"new":["(a) any incident in respect of devices made","available on the Union market;"],"old":["(a) any serious incident in respect of","devices made available on the Union","market;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"307","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-198","location":[[" Proposal for a regulation","Article 26 \u2013 paragraph 7"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:45"},"new":["7. Member States shall provide the","Commission, the other Member States and","the public with all information on their","procedures for the assessment, designation","and notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto."],"old":["7. Member States shall provide the","Commission and the other Member States","with information on their procedures for","the assessment, designation and","notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"198","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-308","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:44"},"new":["The Member States shall take all","appropriate measures, including targeted","information campaigns, to encourage","healthcare professionals, users and patients","to report to their competent authorities","suspected serious incidents referred to in","point (a) of paragraph 1. They shall record","such reports centrally at national level.","Where a competent authority of a Member","State obtains such reports, it shall inform","the manufacturer of the device concerned","without delay. The manufacturer shall","ensure the appropriate follow-up.","Where a competent authority of a member","State ascertains that the reports received","pursuant to the first subparagraph relate","to a serious incident it shall notify those","reports to the electronic system referred to","in Article 60 without delay, unless the","same incident has already been reported","by the manufacturer."],"old":["The Member States shall take all","appropriate measures to encourage","healthcare professionals, users and patients","to report to their competent authorities","suspected serious incidents referred to in","point (a) of paragraph 1. They shall record","such reports centrally at national level.","Where a competent authority of a Member","State obtains such reports, it shall take the","necessary steps to ensure that the","manufacturer of the device concerned is","informed of the incident. The","manufacturer shall ensure the","appropriate follow-up."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"308","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Alda Sousa, Margrete Auken, Paolo Bartolozzi, Anne Delvaux, Anna Rosbach, Thomas Ulmer, Zofija Mazej Kukovi\u010d, Renate Sommer, Miroslav Mikol\u00e1\u0161ik","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-309","justification":" This provision reflects the approach taken in the Pharmacovigilance Directive.","location":[["Proposal for a regulation","Article 59 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[1927,113487,28161,21818,96914,96664,28221,39916,4282,28178],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Member States shall take all","appropriate measures to encourage","healthcare professionals, including doctors","and pharmacists, users and patients to","report to their competent authorities","suspected serious incidents referred to in","point (a) of paragraph 1. They shall record","such reports centrally at national level.","Where a competent authority of a Member","State obtains such reports, it shall take the","necessary steps to ensure that the","manufacturer of the device concerned is","informed of the incident. The manufacturer","shall ensure the appropriate follow-up."],"old":["The Member States shall take all","appropriate measures to encourage","healthcare professionals, users and patients","to report to their competent authorities","suspected serious incidents referred to in","point (a) of paragraph 1. They shall record","such reports centrally at national level.","Where a competent authority of a Member","State obtains such reports, it shall take the","","necessary steps to ensure that the","manufacturer of the device concerned is","informed of the incident. The manufacturer","shall ensure the appropriate follow-up."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"309","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-199","location":[["Proposal for a regulation","Article 26 \u2013 paragraph 7"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["7. Member States shall provide the","Commission and the other Member States","with all information they request on their","procedures for the assessment, designation","and notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto."],"old":["7. Member States shall provide the","Commission and the other Member States","with information on their procedures for","the assessment, designation and","notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"199","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-310","justification":" Reporting the use of replacement parts or components should allow competent authorities to\n identify problems originating from replacement parts or components quickly","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 3 \u2013 subparagraph 1 a (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:45"},"new":["The reporting of suspected serious","incidents shall take into account whether","parts or components have been replaced,","as specified in Article 19."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"310","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-311","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 3 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Commission, in cooperation with the","Member States and in consultation with","relevant partners including patient and","consumer organisations, shall develop","standard forms for electronic and non-","electronic reporting of serious incidents by","healthcare professionals, users and","patients."],"old":["The Member States shall coordinate","between them the development of","standard web-based structured forms for","","reporting of serious incidents by healthcare","professionals, users and patients."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"311","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-200","location":[["Proposal for a regulation","Article 26 \u2013 paragraph 8 \u2013 subparagraph 2"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Member States shall draw up the","annual plan for the peer-review, ensuring","an appropriate rotation in respect of","reviewing and reviewed authorities, and","submit it to the Commission for scrutiny.","The Commission may participate in the","review. The outcome of the peer-review","shall be communicated to all Member","States and to the Commission and a","summary of the outcome shall be made","publicly available."],"old":["The Member States shall draw up the","annual plan for the peer-review, ensuring","an appropriate rotation in respect of","reviewing and reviewed authorities, and","submit it to the Commission. The","Commission may participate in the review.","The outcome of the peer-review shall be","communicated to all Member States and to","the Commission and a summary of the","outcome shall be made publicly available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"200","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor, Marina Yannakoudakis","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-312","justification":"The in-house exemption for devices manufactured and used within a single Health Institution\nshould be subject to reporting requirements. The European Commission, when reviewing\nlegislation in this field in the future, will benefit from access to this information.","location":[["Proposal for a regulation","Article 60 \u2013 paragraph 1 \u2013 point f a (new)"]],"meps":[112620,96944],"meta":{"created":"2019-07-03T05:26:45"},"new":["(f a) the reports by competent authorities","on serious incidents and field safety","corrective actions taken within Health","Institutions involving devices referred to","in Article 4(4)"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"312","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-201","location":[["Proposal for a regulation","Article 26 \u2013 paragraph 8 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["The Member States shall draw up the","annual plan for the peer-review, ensuring","an appropriate rotation in respect of","reviewing and reviewed authorities, and","submit it to the Commission. The","Commission shall participate in the","review. The outcome of the peer-review","shall be communicated to all Member","States and to the Commission and a","summary of the outcome shall be made","publicly available."],"old":["The Member States shall draw up the","annual plan for the peer-review, ensuring","an appropriate rotation in respect of","reviewing and reviewed authorities, and","submit it to the Commission. The","Commission may participate in the review.","The outcome of the peer-review shall be","communicated to all Member States and to","the Commission and a summary of the","outcome shall be made publicly available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"201","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-313","justification":" Healthcare professionals and the public will benefit from an overview of vigilance and market\n surveillance information. As this information will require sensitive handling, the MDCG is the\n appropriate forum for providing this information for the European Databank","location":[["Proposal for a regulation","Article 60 \u2013 paragraph 2"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:45"},"new":["2. The information collated and processed","by the electronic system shall be accessible","to the competent authorities of the Member","States, to the Commission and to the","notified bodies. The Commission, in","consultation with the Medical Devices","Coordination Group, shall provide an","overview of this information, every 6","months, for the public and healthcare","professionals. This information shall be","accessible through the European","databank in Article 25."],"old":["2. The information collated and processed","by the electronic system shall be accessible","to the competent authorities of the Member","States, to the Commission and to the","notified bodies.","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"313","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-202","location":[[" Proposal for a regulation","Article 27 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["1. Notified bodies shall satisfy the","organisational and general requirements","and the quality management, resource and","process requirements that are necessary to","fulfil their tasks for which they are","designated in accordance with this","Regulation. 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The information collated and processed","by the electronic system shall be accessible","to the competent authorities of the Member","States, to the Commission and to the","notified bodies."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"314","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-315","location":[[" Proposal for a regulation","Article 60 \u2013 paragraph 3"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["3. The Commission shall ensure that the","public has an appropriate level of access to","the electronic system. In particular, it","shall ensure that, in case information is","requested on a specific in vitro diagnostic","medical device, it is made available","without delay and within 15 days."],"old":["3. The Commission shall ensure that","healthcare professionals and the public","","","have appropriate levels of access to the","electronic system."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"315","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-203","location":[["Proposal for a regulation","Article 28 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:45"},"new":["1. Notified body shall have permanent \"in","house\" competent personnel and","expertise, both in technical fields linked","with the assessment of the performance of","the devices, and in the medical field. They","shall have the capacity to evaluate \"in","house\" the quality of subcontractors.","Subcontracting shall be awarded to public","entities. 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The control by effective testing of\n samples on the market, outside of the manufacturer\u2019s facilities, would be cost-effective and\n not needing additional resources. This shift from batch release control to unannounced post-\n market control will better detect fraud, counterfeit and defective products and ensure a cost-\n efficient system of control.","location":[["Proposal for a regulation","Article 78 \u2013 paragraph 2 \u2013 point b"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:46"},"new":["(b) to carry out appropriate tests on","samples of manufactured class D devices","on request of competent authorities on","samples collected during market","surveillance activities under article 65 and","of notified bodies on samples collected","during unannounced inspections under","Annex VIII section 4.4;"],"old":["(b) to carry out appropriate tests on","samples of manufactured class D devices","or batches of class D devices, as provided","for in the Section 5.7 of Annex VIII and","in Section 5.1 of Annex X;","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"332","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-212","location":[["Proposal for a regulation","Article 30 \u2013 paragraph 4 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["Findings regarding non-compliance of an","applicant conformity assessment body","with the requirements set out in Annex VI","shall be raised during the assessment","process and discussed between the national","authority responsible for notified bodies","and the joint assessment team. The","national authority shall set out in the","assessment report the measures it will","take to ensure compliance of that","applicant conformity assessment body","with the requirements set out in Annex","VI."],"old":["Findings regarding non-compliance of a","body with the requirements set out in","Annex VI shall be raised during the","assessment process and discussed between","the national authority responsible for","notified bodies and the joint assessment","team with a view to finding common","agreement with respect to the assessment","of the application. Divergent opinions","shall be identified in the assessment report","of the national authority responsible."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"212","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-333","justification":" Improved wording and clearer definition of the tasks of the Reference laboratories","location":[[" Proposal for a regulation","Article 78 \u2013 paragraph 2 \u2013 point d"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:46"},"new":["(d) to provide scientific advice and","technical assistance regarding the","definition of the state of the art in relation","to specific devices, or a category or group","of devices;"],"old":["(d) to provide scientific advice regarding","the state of the art in relation to specific","devices, or a category or group of devices;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"333","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-334","justification":"The task of Reference Laboratories to be responsible also for batch verification of class D\nIVD has to be described in Article 78.","location":[[" Proposal for a regulation","Article 78 \u2013 paragraph 2 \u2013 point f"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:46"},"new":["(f) to contribute to the development of","appropriate testing and analysis methods to","be applied for conformity assessment","procedures, in particular for batch","verification of class D devices and for","market surveillance;"],"old":["(f) to contribute to the development of","appropriate testing and analysis methods to","be applied for conformity assessment","procedures and market surveillance;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"334","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-213","location":[[" Proposal for a regulation","Article 30 \u2013 paragraph 6"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:46"},"new":["6. The joint assessment team shall provide","its opinion regarding the assessment report","and the draft notification within 21 days of","receipt of those documents and the","Commission shall immediately submit this","opinion to the MDCG. Within 21 days","after receipt of the opinion of the joint","assessment team, the MDCG shall issue a","binding recommendation with regard to the","draft notification. The relevant national","authority shall fully respect this binding","recommendation for its decision on the","designation of the notified body."],"old":["6. The joint assessment team shall provide","its opinion regarding the assessment report","and the draft notification within 21 days of","receipt of those documents and the","Commission shall immediately submit this","opinion to the MDCG. Within 21 days","after receipt of the opinion of the joint","assessment team, the MDCG shall issue a","recommendation with regard to the draft","notification which the relevant national","authority shall duly take into consideration","for its decision on the designation of the","notified body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"213","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese, Nora Berra","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-335","justification":"Reference Laboratories will have the appropriate knowledge, experience and technical skills\nto contribute to the development of CTS. Improvement of the wording.","location":[["Proposal for a regulation","Article 78 \u2013 paragraph 2 \u2013 point i"]],"meps":[1927,96947],"meta":{"created":"2019-07-03T05:26:46"},"new":["(i) to contribute to the development of","common technical specifications (CTS) as","well as of international standards"],"old":["(i) to contribute to the development of","standards at international level;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"335","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-214","location":[["Proposal for a regulation","Article 30 \u2013 paragraph 6"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["6. The joint assessment team shall provide","its opinion regarding the assessment report","and the draft notification within 21 days of","receipt of those documents and the","Commission shall immediately submit this","opinion to the MDCG. Within 21 days","after receipt of the opinion of the joint","assessment team, the MDCG shall issue a","recommendation with regard to the draft","notification. The relevant national authority","shall base its decision on the designation of","the notified body on this recommendation","by the MDCG. In case where its decision","differs from that recommendation, the","national authority shall provide the","MDCG with all necessary justifications."],"old":["6. The joint assessment team shall provide","its opinion regarding the assessment report","and the draft notification within 21 days of","receipt of those documents and the","Commission shall immediately submit this","opinion to the MDCG. Within 21 days","after receipt of the opinion of the joint","assessment team, the MDCG shall issue a","recommendation with regard to the draft","notification which the relevant national","authority shall duly take into consideration","for its decision on the designation of the","notified body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"214","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-336","justification":"Requirements on reference laboratories have to be clearly described.","location":[["Proposal for a regulation","Article 78 \u2013 paragraph 3 \u2013 point a"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:46"},"new":["(a) to have appropriately qualified staff","with adequate knowledge and experience","in the field of the in vitro diagnostic","medical devices for which they are","designated;","appropriate knowledge and experience","shall be based on","- experience of assessing high-risk IVDs","and of carrying out the relevant","laboratory tests;","- in-depth knowledge of high-risk in-vitro","diagnostic medical devices and relevant","technologies;","- proven laboratory experience in one of","the following areas: testing or calibration","laboratory, supervisory authority or","institution, national reference laboratory","for class D devices, quality control of in-","vitro diagnostic medical devices,","development of reference materials for","IVDs, calibration of diagnostic medical","devices; laboratories or blood banks","which experimentally assess and use","high-risk IVDs or, where applicable,","manufacture them in-house;","- knowledge and experience of product or","batch testing, quality checks, design,","manufacture and use of IVDs;","- knowledge of the health risks faced by","patients, their partners and recipients of","blood/organ/tissue donations/preparations","associated with the use and, in particular,","malfunctioning of high-risk IVDs;","- knowledge of this Regulation and of","applicable laws, rules and guidelines,","knowledge of the Common Technical","Specifications (CTS), applicable","harmonized standards, product-specific","requirements and relevant guidance","documents;","- participation in relevant external and","internal quality assessment schemes","organised by international or national","organisations."],"old":["(a) to have appropriately qualified staff","with adequate knowledge and experience","in the field of the in vitro diagnostic","medical devices for which they are","designated;","",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"336","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-215","location":[["Proposal for a regulation","Article 31 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["2. Member States shall notify only","conformity assessment bodies which","satisfy the requirements set out in Annex","VI."],"old":["2. Member States may notify only","conformity assessment bodies which","satisfy the requirements set out in Annex","VI."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"215","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-337","justification":"The fees should fully cover the costs to avoid distortion of competition between the reference\nlaboratories","location":[["Proposal for a regulation","Article 78 \u2013 paragraph 5"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:46"},"new":["5. Where notified bodies or Member States","request scientific or technical assistance or","a scientific opinion from an EU reference","laboratory, they shall be required to pay","fees to wholly cover the costs incurred by","that laboratory in carrying out the","requested task according to a set of","predetermined and transparent terms and","conditions."],"old":["5. 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Where a national authority responsible","for notified bodies is responsible for","designation of notified bodies in the field","of products other than in vitro diagnostic","medical devices, the competent authority","for in vitro diagnostic medical devices","shall provide, prior to the notification, a","positive opinion on the notification and its","scope."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"216","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-338","location":[["Proposal for a regulation","Article 79 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Commission and the Member States","shall take all appropriate measures to","ensure the establishment of registers for in","vitro diagnostic devices to gather post-","market experience related to the use of","such devices. registers for class C and D","shall be systematically established. Such","registers shall contribute to the independent","evaluation of the long-term safety and","performance of devices."],"old":["The Commission and the Member States","shall take all appropriate measures to","encourage the establishment of registers","for specific types of devices to gather post-","market experience related to the use of","such devices. Such registers shall","contribute to the independent evaluation of","the long-term safety and performance of","devices."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"338","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-217","location":[[" Proposal for a regulation","Article 31 \u2013 paragraph 5"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:46"},"new":["5. The notification shall be accompanied","by the final assessment report of the","national authority responsible for notified","bodies, the opinion of the joint assessment","team and the binding recommendation of","the MDCG. Where the notifying Member","State does not agree with the","recommendation of the MDCG, it may","provide a duly substantiated","argumentation for its opinion that will be","publicly available."],"old":["5. The notification shall be accompanied","by the final assessment report of the","national authority responsible for notified","bodies, the opinion of the joint assessment","team and the recommendation of the","MDCG. Where the notifying Member State","does not follow the recommendation of the","MDCG, it shall provide a duly","substantiated justification."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"217","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-339","location":[[" Proposal for a regulation","Chapter 9 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["Chapter IX Chapter X","Confidentiality, data protection, funding,","penalties"],"old":["Confidentiality, data protection, funding,","penalties"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"339","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-218","location":[["Proposal for a regulation","Article 31 \u2013 paragraph 8"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["8. When a Member State or the","Commission raises objections in","accordance with paragraph 7, the effect of","the notification shall be immediately","suspended. In this case, the Commission","shall bring the matter before the MDCG","within 15 days after expiry of the period","referred to in paragraph 7. After consulting","the parties involved, the MDCG shall give","its opinion at the latest within 28 days after","the matter has been brought before it. If the","notifying Member State does not agree","with the opinion of the MDCG, it may","request the Commission to give its opinion."],"old":["8. When a Member State or the","Commission raises objections in","accordance with paragraph 7, the effect of","the notification shall be suspended. In this","case, the Commission shall bring the","matter before the MDCG within 15 days","after expiry of the period referred to in","paragraph 7. After consulting the parties","involved, the MDCG shall give its opinion","at the latest within 28 days after the matter","has been brought before it. If the notifying","Member State does not agree with the","opinion of the MDCG, it may request the","Commission to give its opinion."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"218","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-219","location":[["Proposal for a regulation","Article 32 \u2013 paragraph 2"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:46"},"new":["2. The Commission shall make accessible","to the public the list of the bodies notified","under this Regulation, including the","identification numbers that have been","assigned to them, the activities for which","they have been notified and all documents","for the notification procedure as referred","to in Article 31(5). The Commission shall","ensure that the list is kept up to date."],"old":["2. The Commission shall make accessible","to the public the list of the bodies notified","under this Regulation, including the","identification numbers that have been","assigned to them and the activities for","which they have been notified. The","Commission shall ensure that the list is","kept up to date."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"219","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-340","location":[[" Proposal for a regulation","Article 82 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["This Regulation shall be without prejudice","to the possibility for Member States to levy","fees for the activities set out in this","Regulation, provided that the level of the","fees is comparable and set in a transparent","manner and on the basis of cost recovery","principles. They shall inform the","Commission and the other Member States","at least three months before the structure","and level of fees is to be adopted."],"old":["This Regulation shall be without prejudice","to the possibility for Member States to levy","fees for the activities set out in this","Regulation, provided that the level of the","fees is set in a transparent manner and on","the basis of cost recovery principles. They","","shall inform the Commission and the other","Member States at least three months before","the structure and level of fees is to be","adopted."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"340","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-220","location":[[" Proposal for a regulation","Article 32 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["2. The Commission shall make easily","accessible to the public the list of the","bodies notified under this Regulation,","including the identification numbers that","have been assigned to them and the","activities for which they have been","notified. The Commission shall ensure that","the list is kept up to date."],"old":["2. The Commission shall make accessible","to the public the list of the bodies notified","under this Regulation, including the","identification numbers that have been","assigned to them and the activities for","which they have been notified. The","Commission shall ensure that the list is","kept up to date."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"220","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-341","location":[["Proposal for a regulation","Article 83 \u2013 paragraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","necessary to ensure that they are","implemented and sufficiently dissuasive.","The penalties provided for shall be","effective, proportionate, and dissuasive.","The Member States shall notify those","provisions to the Commission by [3","months prior to the date of application of","this Regulation] and shall notify it without","delay of any subsequent amendment","affecting them."],"old":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","necessary to ensure that they are","implemented. The penalties provided for","shall be effective, proportionate, and","dissuasive. The Member States shall notify","those provisions to the Commission by [3","months prior to the date of application of","this Regulation] and shall notify it without","delay of any subsequent amendment","affecting them."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"341","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-221","location":[[" Proposal for a regulation","Article 33 \u2013 paragraph 1 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:46"},"new":["Notified bodies shall, without delay, and at","least within 15 days, inform the national","authority responsible for notified bodies of","any changes, in particular regarding their","personnel, facilities, subsidiaries or","subcontractors, which may affect","compliance with the requirements set out","in Annex VI or their ability to conduct the","conformity assessment procedures relating","to the devices for which they have been","designated."],"old":["Notified bodies shall, without delay,","inform the national authority responsible","for notified bodies of any changes, in","particular regarding their personnel,","facilities, subsidiaries or subcontractors,","which may affect compliance with the","requirements set out in Annex VI or their","ability to conduct the conformity","assessment procedures relating to the","devices for which they have been","designated."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"221","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-222","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["2. Notified bodies shall respond without","delay, and at least within 15 days, to","requests relating to conformity assessments","they have carried out, submitted by their or","another Member State\u2019s authority or by the","Commission. The national authority","responsible for notified bodies of the","Member State in which the body is","established shall enforce requests","submitted by authorities of any other","Member State or by the Commission.","Where there is a legitimate reason for not","doing so, the notified bodies shall explain","these reasons and shall consult the","MDCG, which shall then issue a","recommendation. The national authority","responsible for notified bodies shall","comply with the MDCG\u2019s","recommendation."],"old":["2. Notified bodies shall respond without","delay to requests relating to conformity","assessments they have carried out,","submitted by their or another Member","State\u2019s authority or by the Commission.","The national authority responsible for","notified bodies of the Member State in","which the body is established shall enforce","requests submitted by authorities of any","other Member State or by the Commission","unless there is a legitimate reason for not","doing so in which case both sides may","consult the MDCG. The notified body or","their national authority responsible for","notified bodies may request that any","information transmitted to the authorities","of another Member State or to the","Commission shall be treated as","confidential."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"222","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Andr\u00e9s Perell\u00f3 Rodr\u00edguez","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-342","justification":" In order to act as a deterrent to fraudulent conduct and ensure its effectiveness, the penalty\n should be significantly greater than the financial benefit obtained by the producer as a result\n of the infringement or fraud committed.","location":[["Proposal for a regulation","Article 83 \u2013 paragraph 1"]],"meps":[96989],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","necessary to ensure that they are","implemented. The penalties provided for","must be effective, proportionate and","dissuasive. The dissuasive nature of the","penalty shall be determined in relation to","the financial benefit obtained as a result","of the infringement. The Member States","shall notify those provisions to the","Commission by [3 months prior to the date","of application of this Regulation] and shall","notify it without delay of any subsequent","amendment affecting them."],"old":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","","necessary to ensure that they are","implemented. The penalties provided for","must be effective, proportionate and","dissuasive. The Member States shall notify","those provisions to the Commission by [3","months prior to the date of application of","this Regulation] and shall notify it without","delay of any subsequent amendment","affecting them."],"orig_lang":"es","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"342","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-223","location":[["Proposal for a regulation","Article 33 \u2013 paragraph 5"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:47"},"new":["5. The Member States shall report to the","Commission and to the other Member","States, at least once a year, on their","monitoring activities. This report shall be","made publicly available."],"old":["5. The Member States shall report to the","Commission and to the other Member","States, at least once a year, on their","monitoring activities. This report shall","contain a summary which shall be made","publicly available."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"223","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-224","justification":" The joint assessment team and the MDCG should effectively monitor the work of Notified\n Bodies. Giving the MDCG the responsibility to annul the suspension of a Notified Body will\n increase their oversight.","location":[[" Proposal for a regulation","Article 34 \u2013 paragraph 2 \u2013 subparagraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["Where a national authority responsible for","notified bodies has ascertained that a","notified body no longer meets the","requirements set out in Annex VI, or that it","is failing to fulfil its obligations, the","authority shall suspend, restrict, or fully or","partially withdraw the notification,","depending on the seriousness of the failure","to meet those requirements or fulfil those","obligations. Suspension shall apply until a","decision to annul the suspension has been","reached by the MDCG, which shall follow","an assessment by a joint assessment team","designated in accordance with the","procedure described in Article 30(3) and","(4). Where the notified body has ceased its","activity, the national authority responsible","for notified bodies shall withdraw the","notification."],"old":["Where a national authority responsible for","notified bodies has ascertained that a","notified body no longer meets the","requirements set out in Annex VI, or that it","is failing to fulfil its obligations, the","authority shall suspend, restrict, or fully or","partially withdraw the notification,","depending on the seriousness of the failure","to meet those requirements or fulfil those","obligations. A suspension shall not exceed","a period of one year, renewable once for","the same period. Where the notified body","has ceased its activity, the national","authority responsible for notified bodies","shall withdraw the notification."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"224","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-343","location":[[" Proposal for a regulation","Chapter 10 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["Chapter X Chapter XI","Final provisions Final provisions"],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"343","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-225","location":[[" Proposal for a regulation","Article 34 \u2013 paragraph 2 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["The national authority responsible for","notified bodies shall immediately and at","least within 10 days, inform the","Commission and the other Member States","of any suspension, restriction or","withdrawal of a notification."],"old":["The national authority responsible for","","","notified bodies shall immediately inform","the Commission and the other Member","States of any suspension, restriction or","withdrawal of a notification."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"225","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-226","location":[["Proposal for a regulation","Article 34 \u2013 paragraph 4"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["4. The national authority responsible for","notified bodies shall assess whether the","reasons which gave rise to the change to","the notification have an impact on the","certificates issued by the notified body and,","within three months after having notified","the changes to the notification, shall submit","a report on its findings to the Commission","and the other Member States. Where","necessary to ensure the safety of devices on","the market, that authority shall instruct the","notified body to suspend or withdraw,","within a reasonable period of time","determined by the authority, and at the","latest 30 days after the publication of the","report, any certificates which were unduly","issued. If the notified body fails to do so","within the determined period of time, or","has ceased its activity, the national","authority responsible for notified bodies","itself shall suspend or withdraw the","certificates unduly issued."],"old":["4. The national authority responsible for","notified bodies shall assess whether the","reasons which gave rise to the change to","the notification have an impact on the","certificates issued by the notified body and,","within three months after having notified","the changes to the notification, shall submit","a report on its findings to the Commission","and the other Member States. Where","necessary to ensure the safety of devices on","the market, that authority shall instruct the","notified body to suspend or withdraw,","within a reasonable period of time","determined by the authority, any","certificates which were unduly issued. If","the notified body fails to do so within the","determined period of time, or has ceased its","activity, the national authority responsible","for notified bodies itself shall suspend or","withdraw the certificates unduly issued."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"226","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-227","location":[[" Proposal for a regulation","Article 34 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["The authority or the notified body","assuming the functions of the notified body","affected by the change of notification shall","immediately and at least within 10 days,","inform the Commission, the other Member","States and the other notified bodies thereof."],"old":["The authority or the notified body","assuming the functions of the notified body","affected by the change of notification shall","immediately inform the Commission, the","other Member States and the other notified","bodies thereof."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"227","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-344","location":[[" Proposal for a regulation","Article 90 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["2. It shall apply from [three years after","entry into force]."],"old":["2. It shall apply from [five years after entry","","","into force]."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"344","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-228","justification":" The joint assessment team and the MDCG should effectively monitor the work of Notified\n Bodies. Giving the MDCG the responsibility to annul the suspension of a Notified Body will\n increase their oversight.","location":[[" Proposal for a regulation","Article 35 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["3. Where the Commission, in consultation","with the Medical Devices Coordination","Group, decides that a notified body no","longer meets the requirements for its","notification, it shall inform the notifying","Member State accordingly and request it to","take the necessary corrective measures,","including the suspension, restriction or","withdrawal of the notification, if necessary,","in line with Article 34(2)."],"old":["3. Where the Commission ascertains that a","notified body no longer meets the","requirements for its notification, it shall","inform the notifying Member State","accordingly and request it to take the","necessary corrective measures, including","the suspension, restriction or withdrawal of","the notification if necessary."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"228","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-229","justification":"The coordination group should be an effective forum for discussion, and should allow\nexperience-sharing between Notified Bodies, but also between Notified Bodies and competent\nauthorities","location":[["Proposal for a regulation","Article 37 \u2013 paragraph 1"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Commission, in consultation with the","Medical Devices Coordination Group,","shall ensure that appropriate coordination","and cooperation between notified bodies is","put in place and operated in the form of the","coordination group of notified bodies","referred to in Article 39 of Regulation","[Ref. of future Regulation on medical","devices]."],"old":["The Commission shall ensure that","appropriate coordination and cooperation","between notified bodies is put in place and","operated in the form of the coordination","group of notified bodies referred to in","Article 39 of Regulation [Ref. of future","Regulation on medical devices]."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"229","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-230","location":[["Proposal for a regulation","Article 37 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Commission shall ensure that","appropriate coordination and cooperation","between notified bodies is put in place and","operated in the form of the coordination","group of notified bodies referred to in","Article 39 of Regulation [Ref. of future","Regulation on medical devices]. This","group shall meet on a regular basis and at","least twice a year."],"old":["The Commission shall ensure that","appropriate coordination and cooperation","between notified bodies is put in place and","operated in the form of the coordination","group of notified bodies referred to in","Article 39 of Regulation [Ref. of future","Regulation on medical devices]."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"230","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-345","location":[["Proposal for a regulation","Annex 1 \u2013 part II \u2013 point 6 \u2013 point 6.1 \u2013 point b"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:47"},"new":["(b) the clinical performance, including","measures of clinical validity such as","diagnostic sensitivity, diagnostic","specificity, positive and negative predictive","value, likelihood ratio, expected values in","normal or affected populations; and, where","appropriate, measures of clinical utility.","In the case of companion diagnostics,","evidence of the clinical utility of the","device for the intended purpose (selection","of patients with a previously diagnosed","condition or predisposition eligible for a","targeted therapy) is required. 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The minimum frequency of their\n meetings should be defined in the text","location":[[" Proposal for a regulation","Article 37 \u2013 paragraph 2 a (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["The group shall meet, at the least, every 6","months"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"231","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Daciana Octavia S\u00e2rbu, C\u0103t\u0103lin Sorin Ivan","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-346","justification":" The proposal limits the special attention which should be paid to endocrine disrupters to\n those identified under REACH. This is too restrictive. The forthcoming Commission criteria\n on endocrine disrupters, for example, should also be taken into account.","location":[["Proposal for a regulation","Annex 1 \u2013 part II \u2013 point 7 \u2013 point 7.3"]],"meps":[33989,96857],"meta":{"created":"2019-07-03T05:26:47"},"new":["7.3. The devices shall be designed and","manufactured in such a way as to reduce as","far as possible the risks posed by","substances that may leach or leak from the","device. Special attention shall be given to","substances which are carcinogenic,","mutagenic or toxic to reproduction, in","accordance with Part 3 of Annex VI to","Regulation (EC) No 1272/2008 of the","European Parliament and of the Council of","16 December 2008 on classification,","labelling and packaging of substances and","mixtures, amending and repealing","Directives 67/548/EEC and 1999/45/EC,","and amending Regulation (EC) No","1907/2006, and to substances having","endocrine disrupting properties for which","there is scientific evidence of probable","serious effects to human health."],"old":["7.3. The devices shall be designed and","manufactured in such a way as to reduce as","","far as possible the risks posed by","substances that may leach or leak from the","device. Special attention shall be given to","substances which are carcinogenic,","mutagenic or toxic to reproduction, in","accordance with Part 3 of Annex VI to","Regulation (EC) No 1272/2008 of the","European Parliament and of the Council of","16 December 2008 on classification,","labelling and packaging of substances and","mixtures, amending and repealing","Directives 67/548/EEC and 1999/45/EC,","and amending Regulation (EC) No","1907/2006, and to substances having","endocrine disrupting properties for which","there is scientific evidence of probable","serious effects to human health and which","are identified in accordance with the","procedure set out in Article 59 of","Regulation (EC) No 1907/2006 of the","European Parliament and of the Council","of 18 December 2006 concerning the","Registration, Evaluation, Authorisation","and Restriction of Chemicals (REACH)."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"346","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-232","justification":" The coordination group should be an effective forum for discussion, and should allow\n scrutiny by the Commission and competent authorities. It should be made clear that\n attendance is compulsory if requested by the Commission or MDCG","location":[[" Proposal for a regulation","Article 37 \u2013 paragraph 2 b (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Commission or the MDCG may","request the participation of any notified","body."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"232","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Margrete Auken on behalf of the Verts/ALE Group","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-347","justification":"Sampling, reading and interpreting results are procedures which allow for faulty handling\nand defective manoeuvres when they are carried out by lay persons. Self-tests only make\nsense if they are part of coherent multidisciplinary management of a medical condition.\nWithout proper counselling by doctor, some people may consider that the information made\navailable by the self-testing devices is exact. Proper counselling can also help reduce the\npossible risk of abuse for example pressure or coercion by a partner or an employer.","location":[[" Proposal for a regulation","Annex 1 \u2013 part II \u2013 point 16 a (new)"]],"meps":[28161],"meta":{"created":"2019-07-03T05:26:47"},"new":["16 a. The devices intended for self-testing","help consumers access information about","their health. However, lack of proper","counselling regarding the use of self-","testing devices - such as the sampling,","reading and interpreting results - can lead","to traumatic events and may harm users.","Therefore, Member States should ensure","appropriate counselling conducted by","persons admitted to the medical","profession under the applicable national","legislation before the use of such self-","testing devices that are manufactured to","test for chronic and transmittable","diseases."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"347","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Rebecca Taylor","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-233","justification":"The coordination group should be an effective forum for discussion, and should allow\nexperience-sharing between Notified Bodies, but also between Notified Bodies and competent\nauthorities. The modalities for the functioning of the coordination group should be further\ndeveloped through implementing acts","location":[["Proposal for a regulation","Article 37 \u2013 paragraph 2 c (new)"]],"meps":[112620],"meta":{"created":"2019-07-03T05:26:47"},"new":["The Commission may, by means of","implementing acts, adopt measures setting","out the modalities for the functioning of","the coordination group of notified bodies","as set out in this Article. Those","implementing acts shall be adopted in","accordance with the examination","procedure referred to in Article 84(3)."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"233","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-348","justification":" The current definition of a label does not laboratory-developed tests. Recipients of the results\n generated by such devices should have the same access to the information contained on the\n label as do users of other IVD devices.","location":[["Proposal for a regulation","Annex 1 \u2013 part III \u2013 point 17 \u2013 point 17.1 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:47"},"new":["Each device shall be accompanied by the","information needed to identify the device","and its manufacturer, and communicate","safety and performance related information","to the user, professional or lay, or other","person, as appropriate. 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Such information","may appear on the device itself, on the","packaging or in the instructions for use,","taking into account the following:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"348","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-234","location":[["Proposal for a regulation","Article 38 \u2013 title"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["Fees for the activities of national","authorities"],"old":["Fees"],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"234","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-349","location":[[" Proposal for a regulation","Annex 1 \u2013 part III \u2013 point 17 \u2013 point 17.2 \u2013 paragraph 1 \u2013 point xv"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:47"},"new":["(xv) If the device is intended for single use,","an indication of that fact. The","manufacturer shall provide sufficient","evidence that the device cannot be","reprocessed safely. A manufacturer's","indication of single use shall be consistent","across the Union;"],"old":["(xv) If the device is intended for single use,","an indication of that fact. A manufacturer's","indication of single use shall be consistent","across the Union;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"349","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-235","location":[["Proposal for a regulation","Article 38 \u2013 paragraph 1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:48"},"new":["1. The Member State where the bodies are","established shall levy fees on applicant","conformity assessment bodies and on","notified bodies. These fees shall, wholly or","partly, cover the costs relating to the","activities exercised by the national","authorities responsible for notified bodies","in accordance with this Regulation. These","fees shall be comparable across Member","States and the level of the fees shall be","made public."],"old":["1. The Member State where the bodies are","established shall levy fees on applicant","conformity assessment bodies and on","notified bodies. These fees shall, wholly or","partly, cover the costs relating to the","activities exercised by the national","authorities responsible for notified bodies","in accordance with this Regulation."],"orig_lang":"en","peid":"PE510.740v01-00","reference":"2012/0267(COD)","seq":"235","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.740+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-350","location":[[" Proposal for a regulation","Annex 1 \u2013 part III \u2013 point 17 \u2013 point 17.3 \u2013 point 17.3.1 \u2013 point ii \u2013 indent 2"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:47"},"new":["\u2013 its function (e.g. screening, monitoring,","diagnosis or aid to diagnosis, prognosis,","companion diagnostic);"],"old":["\u2013 its function (e.g. screening, monitoring,","diagnosis or aid to diagnosis);"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"350","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.740-236","location":[[" Proposal for a regulation","Article 38 \u2013 paragraph 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:48"},"new":["2. 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The personnel responsible for","","carrying out audits of the manufacturer's","quality management system shall have the","following proven qualification:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"376","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Radvil\u00f7 Mork\u016bnait\u00f7-Mikul\u00f7nien\u00f7","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-377","location":[[" Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.2 \u2013 point 3.2.6 \u2013 introductory part"]],"meps":[96695],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.2.6. The personnel responsible for","carrying out audits of the manufacturer's","quality management system shall have an","appropriate qualification certified by a","competent authority of a Member State.","Appropriate qualifications are, for","exampl::"],"old":["3.2.6. The personnel responsible for","carrying out audits of the manufacturer's","quality management system shall have the","following proven qualification:"],"orig_lang":"lt","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"377","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-378","location":[[" Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.3 \u2013 point 3.3.1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.3.1. The notified body shall have a","process in place to fully document the","qualification of each personnel involved in","conformity assessment activities and the","satisfaction of the qualification criteria","referred to in Section 3.2."],"old":["3.3.1. The notified body shall have a","process in place to fully document the","qualification of each personnel involved in","conformity assessment activities and the","satisfaction of the qualification criteria","referred to in Section 3.2. Where in","exceptional circumstances the fulfilment","of the qualification criteria set out in","Section 3.2 cannot be fully demonstrated,","the notified body shall appropriately","justify the authorisation of this personnel","to carry out specific conformity","","assessment activities."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"378","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-379","location":[["Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.3 \u2013 point 3.4 \u2013 point 3.4.1"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.4.(-1). Notified body shall have","permanent \"in house\" competent","personnel and expertise, not only in","technical fields linked with the assessment","of the performance of the devices, but also","in the medical sector. They shall have the","capacity to evaluate \"in house\" the","quality of subcontractors. By derogation,","the following paragraphs apply.","3.4.1. Without prejudice to the limitations","emanating from Section 3.2., the notified","bodies may subcontract clearly defined","parts of the conformity assessment","activities to public entities. Contracts can","also be awarded to external experts for the","assessment of innovative medical devices","or technologies where clinical expertise is","limited. The subcontracting of the auditing","of quality management systems or of","product related reviews as a whole is not","allowed."],"old":["3.4.1. Without prejudice to the limitations","emanating from Section 3.2., the notified","bodies may subcontract clearly defined","parts of the conformity assessment","activities. The subcontracting of the","auditing of quality management systems or","of product related reviews as a whole is not","allowed."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"379","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-380","location":[["Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.3 \u2013 point 3.4 \u2013 point 3.4.2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.4.2. Where a notified body subcontracts","conformity assessment activities either to","an organisation or an individual, it shall","have a policy describing the conditions","under which subcontracting may take","place. Any subcontracting or consultation","of external experts shall be properly","documented, be publicly available and be","subject to a written agreement covering,","among others, confidentiality and conflict","of interests."],"old":["3.4.2. Where a notified body subcontracts","conformity assessment activities either to","an organisation or an individual, it shall","have a policy describing the conditions","under which subcontracting may take","place. Any subcontracting or consultation","of external experts shall be properly","documented and be subject to a written","agreement covering, among others,","confidentiality and conflict of interests."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"380","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-381","location":[[" Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.3 \u2013 point 3.4 \u2013 point 3.4.4 a (new)"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.4.4 a. The policy and procedures under","points 3.4.2 and 3.4.4 shall be","communicated to the national authority","before any subcontracting takes place."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"381","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-382","location":[[" Proposal for a regulation","Annex 6 \u2013 point 3 \u2013 point 3.3 \u2013 point 3.5 \u2013 point 3.5.2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:49"},"new":["3.5.2. It shall review the competence of its","personnel and identify training needs and","ensure that necessary measures are taken","accordingly, in order to maintain the","required level of qualification and","knowledge."],"old":["3.5.2. It shall review the competence of its","personnel and identify training needs in","order to maintain the required level of","qualification and knowledge.",""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"382","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-383","location":[["Proposal for a regulation","Annex 6 \u2013 point 4 \u2013 point 4.3 \u2013 introductory part"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:50"},"new":["4.3. The notified body shall have in place","documented procedures that are publicly","available covering at least:"],"old":["4.3. The notified body shall have in place","documented procedures covering at least:"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"383","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Dagmar Roth-Behrendt","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-384","location":[["Proposal for a regulation","Annex 6 \u2013 point 4 \u2013 point 4.3 \u2013 indent 2"]],"meps":[1183],"meta":{"created":"2019-07-03T05:26:50"},"new":["\u2013 the processing of the application,","including the verification of the","completeness of the documentation, the","qualification of the product as in vitro","diagnostic medical device and its","classification, as well as the minimum","time for its audit assessments,"],"old":["\u2013 the processing of the application,","including the verification of the","completeness of the documentation, the","qualification of the product as in vitro","diagnostic medical device and its","classification,"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"384","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-385","location":[["Proposal for a regulation","Annex 7 \u2013 part 1 \u2013 point 1.1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:50"},"new":["1.1. Application of the classification rules","shall be governed by the intended purpose,","novelty, complexity and inherent risk of","the devices."],"old":["1.1. Application of the classification rules","shall be governed by the intended purpose","of the devices."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"385","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-386","location":[[" Proposal for a regulation","Annex 7 \u2013 part 2 \u2013 point 2.3 \u2013 paragraph 1 \u2013 point f \u2013 point i"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:50"},"new":["(i) Devices intended to be used as","companion diagnostics are classified as a","Class C, except when intended to identify","patients at risk of life-threatening adverse","event, or where the selection decision may","lead to the withholding of a potentially","life-saving treatment, in which case they","are Class D"],"old":["(i) Devices intended to be used as","companion diagnostics; or"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"386","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-387","justification":"Disease prognosis is an increasingly common application in the molecular diagnostic sector,\nexemplified by tests such as Agendia\u2019s Mammaprint and Genomic Health\u2019s Oncotype Dx,\nwhich are both used to give prognostic scores for likelihood of disease recurrence in breast\ncancer after surgery. Because prognosis is a form of patient selection, we believe that such\ndevices should explicitly be included under Rule 3.","location":[[" Proposal for a regulation","Annex 7 \u2013 part 2 \u2013 point 2.3 \u2013 paragraph 1 \u2013 point f \u2013 point ii"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:50"},"new":["(ii) Devices intended to be used for disease","staging or prognosis; or"],"old":["(ii) Devices intended to be used for disease","staging; or"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"387","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-388","location":[["Proposal for a regulation","Annex 7 \u2013 part 2 \u2013 point 2.3 \u2013 paragraph 1 \u2013 point j a (new)"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:50"},"new":["(j a) IVDs for the detection and","identification of antibodies directed","against erythrocytes, platelets, or","leucocytes."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"388","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-389","location":[["Proposal for a regulation","Annex 7 \u2013 part 2 \u2013 point 2.6 \u2013 paragraph 1"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:50"},"new":["Devices not covered by the above-","mentioned classification rules are classified","as class B. However, novel class B devices","will be classified as class C."],"old":["Devices not covered by the above-","mentioned classification rules are classified","as class B."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"389","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-390","justification":" It should not be done in regular intervals but in each and every case.","location":[[" Proposal for a regulation","Annex 8 \u2013 section 2 \u2013 point 5 \u2013 point 5.7"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:50"},"new":["5.7. To verify conformity of manufactured","devices classified as class D, the","manufacturer shall carry out tests on the","manufactured devices or each batch of","devices. After the conclusion of the","controls and tests he shall forward to the","notified body without delay the relevant","reports on these tests. Furthermore, the","manufacturer shall make the samples of","manufactured devices or batches of devices","available to the notified body in","accordance with pre-agreed conditions and","modalities which shall include that the","notified body or the manufacturer shall","send samples of the manufactured devices","or batches of devices to a reference","laboratory, where designated in accordance","with Article 78, to carry out appropriate","tests. The reference laboratory shall inform","the notified body about its findings."],"old":["5.7. To verify conformity of manufactured","devices classified as class D, the","manufacturer shall carry out tests on the","manufactured devices or each batch of","devices. After the conclusion of the","controls and tests he shall forward to the","notified body without delay the relevant","reports on these tests. Furthermore, the","manufacturer shall make the samples of","manufactured devices or batches of devices","available to the notified body in","accordance with pre-agreed conditions and","modalities which shall include that the","notified body or the manufacturer, in","regular intervals, shall send samples of the","manufactured devices or batches of devices","to a reference laboratory, where designated","in accordance with Article 78, to carry out","appropriate tests. The reference laboratory","shall inform the notified body about its","findings."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"390","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-391","justification":"This shifts the consultation process to the development of Common Technical Specifications\nfor companion diagnostics, setting up minimal performance requirements for those tests;\nthese requirements would also be available to the users ensuring a better transparency of the\nsystem. In addition, the consultation of EMA or competent authorities for medicinal products\nwould not be appropriate in regard to the performance of the IVD tests to be used together\nwith the personalized medicine. None of them have the necessary competences and mandate\nregarding the assessment of the safety and performance of those tests.","location":[[" Proposal for a regulation","Annex 8 \u2013 section 2 \u2013 point 6 \u2013 point 6.2 \u2013 point c"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:50"},"new":["(c) Before issuing an EU design-","examination certificate, the notified body","shall request a reference laboratory,","where designated in accordance with","Article 78, to verify compliance of the","device with the CTS, when available, or","with other solutions chosen by the","manufacturer to ensure a level of safety","and performance that is at least","equivalent. The reference laboratory shall","provide a scientific opinion within 30","days. The scientific opinion of the","reference laboratory and any possible","updates shall be included in the","documentation of the notified body","concerning the device. The notified body","shall give due consideration to the views","expressed in the scientific opinion when","making its decision. The notified body","shall not deliver the certificate if the","scientific opinion is unfavourable."],"old":["(c) For companion diagnostic intended to","be used to assess the patient eligibility to a","treatment with a specific medicinal","product, the notified body shall consult","","","before issuing an EU design-examination","certificate and on the basis of the draft","summary of safety and performance and","the draft instructions for use, one of the","competent authorities designated by the","Member States in accordance with","Directive 2001/83/EC (hereinafter","referred to as \u2018medicinal products","competent authority\u2019) or the European","Medicines Agency (hereinafter referred to","as \u2018EMA\u2019) established by the Regulation","(EC) No 726/2004 laying down","Community procedures for the","authorisation and supervision of","medicinal products for human and","veterinary use and establishing a","European Medicines Agency, regarding","the suitability of the device in relation to","the medicinal product concerned. Where","the medicinal product falls exclusively","within the scope of the Annex of","Regulation (EC) No 726/2004, the","notified body shall consult the EMA."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"391","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-392","justification":" This shifts the consultation process to the development of Common Technical Specifications\n for companion diagnostics, setting up minimal performance requirements for those tests;\n these requirements would also be available to the users ensuring a better transparency of the\n system. In addition, the consultation of EMA or competent authorities for medicinal products\n would not be appropriate in regard to the performance of the IVD tests to be used together\n with the personalized medicine. None of them have the necessary competences and mandate\n regarding the assessment of the safety and performance of those tests.","location":[["Proposal for a regulation","Annex 8 \u2013 section 2 \u2013 point 6 \u2013 point 6.2 \u2013 point c a (new)"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:50"},"new":["(c a) Changes to the approved design shall","receive further approval from the notified","body which issued the EU design-","examination certificate, wherever the","changes could affect conformity with the","general safety and performance","requirements of this Regulation or with","the conditions prescribed for use of the","device. The applicant shall inform the","notified body which issued the EU design-","examination certificate of any planned","changes to the approved design. The","notified body shall examine the planned","changes, notify the manufacturer of its","decision and provide him with a","supplement to the EU design-examination","report. Where the changes could affect","compliance with the CTS or with other","solutions chosen by the manufacturer","which were approved through the EU","design examination certificate, the","notified body shall consult the reference","laboratory that was involved in the initial","consultation, in order to confirm that","compliance with the CTS or with other","solutions chosen by the manufacturer to","ensure a level of safety and performance","that is at least equivalent are maintained.","The reference laboratory shall provide a","scientific opinion within 30 days. The","approval of any change to the approved","design shall take the form of a supplement","to the EU design-examination certificate."],"old":[""],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"392","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-393","justification":"The Proposal states that the notified body shall give \u201cdue consideration\u201d to the opinion\nexpressed by the EMA. This leaves ample room for interpretation and, while the notified body\nis under no obligation to follow the EMA\u2019s opinion, it seems rather unlikely that they\ndisregard it. We thus need a definition of what happens if the assessments of the EMA and\nnotified body are inconsistent.","location":[["Proposal for a regulation","Annex 8 \u2013 section 2 \u2013 point 6 \u2013 point 6.2 \u2013 point e"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:50"},"new":["(e) The notified body shall give due","consideration to the opinion, if any,","expressed by the medicinal products","competent authority concerned or the EMA","on the scientific suitability of the","companion diagnostic when making its","decision. If the notified body deviates from","that position, it shall justify its decision to","the medicinal products competent authority","concerned or to the EMA. If no agreement","is reached, the notified body shall inform","the MDCG thereof. The design-","examination certificate shall be delivered","in accordance with point (d) of Section 6.1."],"old":["(e) The notified body shall give due","consideration to the opinion, if any,","expressed by the medicinal products","competent authority concerned or the EMA","when making its decision. It shall convey","its final decision to the medicinal products","competent authority concerned or to the","EMA. The design-examination certificate","shall be delivered in accordance with point","(d) of Section 6.1."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"393","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-394","justification":" This shifts the consultation process to the development of Common Technical Specifications\n for companion diagnostics, setting up minimal performance requirements for those tests;\n these requirements would also be available to the users ensuring a better transparency of the\n system. In addition, the consultation of EMA or competent authorities for medicinal products\n would not be appropriate in regard to the performance of the IVD tests to be used together\n with the personalized medicine. None of them have the necessary competences and mandate\n regarding the assessment of the safety and performance of those tests.","location":[["Proposal for a regulation","Annex 9 \u2013 point 3 \u2013 paragraph 1 \u2013 point 3.5"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:50"},"new":["3.5. in the case of devices classified as","class D, or for companion diagnostics,","request a reference laboratory, where","designated in accordance with Article 78,","to verify compliance of the device with the","CTS or with other solutions chosen by the","manufacturer to ensure a level of safety","and performance that is at least equivalent.","The reference laboratory shall provide a","scientific opinion within 30 days. The","scientific opinion of the reference","laboratory and any possible update shall be","included in the documentation of the","notified body concerning the device. The","notified body shall give due consideration","to the views expressed in the scientific","opinion when making its decision. The","notified body shall not deliver the","certificate if the scientific opinion is","unfavourable;"],"old":["3.5. in the case of devices classified as","class D, request a reference laboratory,","where designated in accordance with","Article 78, to verify compliance of the","","","device with the CTS or with other solutions","chosen by the manufacturer to ensure a","level of safety and performance that is at","least equivalent. The reference laboratory","shall provide a scientific opinion within 30","days. The scientific opinion of the","reference laboratory and any possible","update shall be included in the","documentation of the notified body","concerning the device. The notified body","shall give due consideration to the views","expressed in the scientific opinion when","making its decision. The notified body","shall not deliver the certificate if the","scientific opinion is unfavourable;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"394","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-395","justification":"This shifts the consultation process to the development of Common Technical Specifications\nfor companion diagnostics, setting up minimal performance requirements for those tests;\nthese requirements would also be available to the users ensuring a better transparency of the\nsystem. In addition, the consultation of EMA or competent authorities for medicinal products\nwould not be appropriate in regard to the performance of the IVD tests to be used together\nwith the personalized medicine. None of them have the necessary competences and mandate\nregarding the assessment of the safety and performance of those tests.","location":[[" Proposal for a regulation","Annex 9 \u2013 point 3 \u2013 paragraph 1 \u2013 point 3.6"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:50"},"new":["deleted"],"old":["3.6. For companion diagnostic intended to","be used to assess the patient eligibility to a","treatment with a specific medicinal","product, seek the opinion, on the basis of","the draft summary of safety and","performance and the draft instructions for","use, of a one of the competent authorities","designated by the Member States in","","accordance with Directive 2001/83/EC","(hereinafter referred to as \u2018medicinal","products competent authority\u2019) or the","European Medicines Agency (hereinafter","referred to as \u2018EMA\u2019) on the suitability of","the device in relation to the medicinal","product concerned. Where the medicinal","product falls exclusively within the scope","of the Annex of Regulation (EC) No","726/2004, the notified body shall consult","the EMA. The medicinal products","authority or the European Medicines","Agency shall deliver its opinion, if any,","within 60 days upon receipt of the valid","documentation. This 60-day period may","be extended only once for a further 60","days on scientifically valid grounds. The","opinion of the medicinal products","authority or of the EMA and any possible","update shall be included in the","documentation of the notified body","concerning the device. The notified body","shall give due consideration to the","opinion, if any, expressed by the","medicinal products competent authority","concerned or the EMA when making its","decision. It shall convey its final decision","to the medicinal products competent","authority concerned or to the EMA."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"395","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anna Rosbach","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-396","justification":" This shifts the consultation process to the development of Common Technical Specifications\n for companion diagnostics, setting up minimal performance requirements for those tests;\n these requirements would also be available to the users ensuring a better transparency of the\n system. In addition, the consultation of EMA or competent authorities for medicinal products\n would not be appropriate in regard to the performance of the IVD tests to be used together\n with the personalized medicine. None of them have the necessary competences and mandate\n regarding the assessment of the safety and performance of those tests.","location":[[" Proposal for a regulation","Annex 9 \u2013 point 5 \u2013 point 5.4"]],"meps":[96664],"meta":{"created":"2019-07-03T05:26:50"},"new":["deleted"],"old":["5.4. Where the changes affect a","companion diagnostic approved through","the EU type-examination certificate with","regard to its suitability in relation to a","medicinal product, the notified body shall","consult the medicinal products competent","authority that was involved in the initial","consultation or the EMA. The medicinal","products competent authority or the EMA","shall give its opinion, if any, within 30","days after receipt of the valid","documentation regarding the changes.","The approval of any change to the","approved type shall take the form of a","supplement to the initial EU type-","examination certificate."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"396","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Peter Liese","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-397","justification":"Clarification that it has to be laboratory testing and not only a \"paper test\"","location":[[" Proposal for a regulation","Annex 10 \u2013 point 5 \u2013 point 5.1"]],"meps":[1927],"meta":{"created":"2019-07-03T05:26:50"},"new":["5.1. In the case of devices classified as","class D, the manufacturer shall carry out","tests on the manufactured devices or each","batch of devices. After the conclusion of","the controls and tests he shall forward to","the notified body without delay the","relevant reports on these tests.","Furthermore, the manufacturer shall make","the samples of manufactured devices or","batches of devices available to the notified","body in accordance with pre-agreed","conditions and modalities which shall","include that the notified body or the","manufacturer shall send samples of the","manufactured devices or batches of devices","to a reference laboratory, where designated","in accordance with Article 78, to carry out","appropriate laboratory tests. The reference","laboratory shall inform the notified body","about its findings"],"old":["5.1. In the case of devices classified as","class D, the manufacturer shall carry out","tests on the manufactured devices or each","","","batch of devices. After the conclusion of","the controls and tests he shall forward to","the notified body without delay the","relevant reports on these tests.","Furthermore, the manufacturer shall make","the samples of manufactured devices or","batches of devices available to the notified","body in accordance with pre-agreed","conditions and modalities which shall","include that the notified body or the","manufacturer, in regular intervals, shall","send samples of the manufactured devices","or batches of devices to a reference","laboratory, where designated in accordance","with Article 78, to carry out appropriate","tests. The reference laboratory shall inform","the notified body about its findings"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"397","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-398","location":[["Proposal for a regulation","Annex 12 \u2013 section 1 \u2013 point 1 \u2013 point 1.2.2 \u2013 point 1.2.2.6 \u2013 indent 2"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:51"},"new":["\u2013 For devices classified as class C and","class D according to the rules set out in","Annex VII, the clinical performance study","report shall include the method of data","analysis, the study conclusion, the relevant","details of the study protocol and the","individual data points."],"old":["\u2013 For devices classified as class C","according to the rules set out in Annex VII,","the clinical performance study report shall","include the method of data analysis, the","study conclusion and the relevant details of","the study protocol;"],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"398","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Alda Sousa","changes":{},"committee":["ENVI"],"date":"2013-05-13T00:00:00","id":"PE510.755-399","location":[[" Proposal for a regulation","Annex 12 \u2013 section 1 \u2013 point 1 \u2013 point 1.2.2 \u2013 point 1.2.2.6 \u2013 indent 3"]],"meps":[113487],"meta":{"created":"2019-07-03T05:26:51"},"new":["deleted"],"old":["\u2013 For devices classified as class D","according to the rules set out in Annex","VII, the clinical performance study report","shall include the method of data analysis,","the study conclusion, the relevant details","of the study protocol and the individual","data points."],"orig_lang":"en","peid":"PE510.755v01-00","reference":"2012/0267(COD)","seq":"399","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.755+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-48","location":[["Proposal for a regulation","Recital 27"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:35"},"new":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase policy and stock","management by hospitals, pharmacies and","wholesalers. The UDI system should be","compatible with other systems already on","the market."],"old":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals."],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"48","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nora Berra","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-49","location":[["Proposal for a regulation","Recital 27"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:35"},"new":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase policy and stock","management by hospitals, and, where","possible, the system should be compatible","with the other authentication systems","already in place in such environments."],"old":["(27) The traceability of in vitro diagnostic","medical devices by means of a Unique","Device Identification (UDI) system based","on international guidance should","significantly enhance the effectiveness of","the post-market safety of in vitro","diagnostic medical devices due to","improved incident reporting, targeted field","","safety corrective actions and better","monitoring by competent authorities. It","should also help to reduce medical errors","and to fight against counterfeit devices.","Use of the UDI system should also","improve purchase-policy and stock-","management by hospitals."],"orig_lang":"fr","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"49","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Toine Manders","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-50","location":[[" Proposal for a regulation","Recital 63"]],"meta":{"created":"2019-07-03T05:35:35"},"new":["(63) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to the","extension to the territory of the Union of a","national derogation from the applicable","conformity assessment procedures in","exceptional cases; relating to the","Commission's position whether a","provisional national measure against an in","vitro diagnostic medical device presenting","a risk or a provisional national preventive","health protection measure is justified or","not; and relating to the adoption of a Union","measure against an in vitro diagnostic","medical device presenting a risk,","imperative grounds of urgency so require.","This justification should be evaluated","within a reasonable amount of time in","order to ensure that these implementing","acts are adequate."],"old":["(63) The Commission should adopt","immediately applicable implementing acts","where, in duly justified cases relating to the","extension to the territory of the Union of a","national derogation from the applicable","conformity assessment procedures in","exceptional cases; relating to the","Commission's position whether a","provisional national measure against an in","vitro diagnostic medical device presenting","a risk or a provisional national preventive","health protection measure is justified or","not; and relating to the adoption of a Union","measure against an in vitro diagnostic","medical device presenting a risk,","imperative grounds of urgency so require."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"50","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-51","justification":"General purpose consumer technology is increasingly used in healthcare settings. A generic\nconsumer product may assist a medical device in its functioning but not potentially affect the\nsafety and performance of the medical device itself.","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 3"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:35"},"new":["(3) 'accessory to an in vitro diagnostic","medical device' means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable the","in vitro diagnostic medical device(s) to be","used in accordance with its/their intended","purpose(s) or to specifically assist the","medical functionality of the in vitro","diagnostic medical device(s) in view of","its/their intended purpose(s);"],"old":["(3) \u2018accessory to an in vitro diagnostic","medical device\u2019 means an article which,","whilst not being an in vitro diagnostic","medical device, is intended by its","manufacturer to be used together with one","or several particular in vitro diagnostic","medical device(s) to specifically enable or","assist the in vitro diagnostic medical","device(s) to be used in accordance with","its/their intended purpose(s);"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"51","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nora Berra","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-52","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 6"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:35"},"new":["(6) \u2018companion diagnostic\u2019 means a device","specifically intended to and essential in","selecting patients with a previously","diagnosed condition or predisposition as","suitable or not suitable eligible for a","targeted therapy with a medicinal product","or a range of medicinal products;"],"old":["(6) \u2018companion diagnostic\u2019 means a device","specifically intended to select patients with","a previously diagnosed condition or","predisposition as eligible for a targeted","therapy;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"52","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-53","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 21"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:35"},"new":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health, with the","exclusion of laboratories providing","commercial clinical services;"],"old":["(21) \u2018health institution\u2019 means an","organisation whose primary purpose is the","care or treatment of patients or the","promotion of public health;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"53","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-54","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 28"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:35"},"new":["(28) 'clinical evidence' means the data,","positive and negative, supporting the","evaluation of the scientific validity and","performance for the use of a device as","intended by the manufacturer;"],"old":["(28) \u2018clinical evidence\u2019 means the","information that supports the scientific","validity and performance for the use of a","device as intended by the manufacturer;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"54","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-55","location":[[" Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 30"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:35"},"new":["(30) 'performance of a device' means the","ability of a device to achieve its intended","purpose as claimed by the manufacturer. It","consists of attainment of technical","capabilities, analytical performance and,","where applicable, the clinical performance","supporting the intended purpose of the","device;"],"old":["(30) \u2018performance of a device\u2019 means the","ability of a device to achieve its intended","purpose as claimed by the manufacturer. It","consists of the analytical and, where","applicable, the clinical performance","supporting the intended purpose of the","device;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"55","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-56","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 35"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:35"},"new":["(35) 'performance evaluation' means the","assessment and analysis of data to establish","or verify that the device performs as","intended by the manufacturer, including","the technical, analytical and, where","applicable, the clinical performance of a","device;"],"old":["(35) \u2018performance evaluation\u2019 means the","assessment and analysis of data to establish","or verify the analytical and, where","applicable, the clinical performance of a","device;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"56","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-57","location":[["Proposal for a regulation","Article 2 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point 45"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:35"},"new":["(45) \u2018sponsor\u2019 means any individual,","company, institution or organisation which","takes responsibility for the initiation,","management or financing of a clinical","performance study;"],"old":["(45) \u2018sponsor\u2019 means any individual,","company, institution or organisation which","takes responsibility for the initiation and","management of a clinical performance","","study;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"57","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ashley Fox","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-58","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[96957],"meta":{"created":"2019-07-03T05:35:35"},"new":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified manufactured","and used only within a single health","institution, provided manufacture and use","occur solely under a single quality","management system, and the health","institution is accredited to standard EN","ISO 15189 or any other equivalent","recognised standard. Health institutions","shall provide to their competent authority","a list of such devices which shall include","justification of their use, in particular","where equivalent devices have been made","available on the market. This information","shall be made public. Member States may","also make the manufacture and use of the","devices concerned subject to further safety","requirements."],"old":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set","out in Annex VII, and manufactured and","used only within a single health institution,","provided manufacture and use occur solely","under the health institution's single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit","to the competent authority a list of such","devices which have been manufactured","and used on their territory and may make","the manufacture and use of the devices","concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"58","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-59","justification":"Such medical devices will not enter and will not be available on the market, which this\nlegislation seeks to regulate. Healthcare institutions shall be liable to fulfil safety standards\nfor class D in-house diagnostics.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:35"},"new":["With the exception of Article 59(4), the","requirements of this Regulation shall not","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution's single quality","management system, and the health","institution is accredited with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"old":["With the exception of Article 59(4), the","requirements of this Regulation shall not","","apply to devices classified as class A, B","and C, in accordance with the rules set out","in Annex VII, and manufactured and used","only within a single health institution,","provided manufacture and use occur solely","under the health institution's single quality","management system, and the health","institution is compliant with standard EN","ISO 15189 or any other equivalent","recognised standard. Member States may","require that the health institutions submit to","the competent authority a list of such","devices which have been manufactured and","used on their territory and may make the","manufacture and use of the devices","concerned subject to further safety","requirements."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"59","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ashley Fox","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-60","location":[["Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2"]],"meps":[96957],"meta":{"created":"2019-07-03T05:35:35"},"new":["deleted"],"old":["Devices classified as class D in","accordance with the rules set out in","Annex VII, even if manufactured and","used within a single health institution,","shall comply with the requirements of this","Regulation. However, the provisions","regarding CE marking set out in Article","16 and the obligations referred to in","Articles 21 to 25 shall not apply to those","devices."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"60","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-61","justification":" Such medical devices will not enter and will not be available on the market, which this\n legislation seeks to regulate. Healthcare institutions shall be liable to fulfil safety standards\n for class D in-house diagnostics.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2 a (new)"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["By way of derogation from the first","subparagraph, devices classified as class","D and required to be used for transfusion","or transplantation purposes, may be","manufactured and used within a single","health institution without fulfilling the","full requirements of this Regulation,","provided that they comply with the","conditions defined in the first","subparagraph, essential requirements in","Annex I, applicable harmonized standards","referred to in Article 6 and applicable","common technical specifications referred","to in Article 7. This derogation is","applicable only if, and for as long as such","devices are not available on the market as","CE marked."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"61","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-62","justification":"For the detection of rare or infrequent transmissible agents where no CE marked are\navailable, \"in house\" class D devices should be exempted from some requirements of the\nregulation. However, to demonstrate compliance with state of the art quality and safety\nrequirements these IVDs shall comply with the essential requirements (Annex I), harmonized\nstandards and applicable common technical specifications.","location":[[" Proposal for a regulation","Article 4 \u2013 paragraph 5 \u2013 subparagraph 2 a (new)"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:36"},"new":["In addition, devices classified as class D","and required to be used for transfusion or","transplantation purposes, when not","available as CE marked, or available as","CE marked but not reaching the","appropriate standards or specifications","required by the users, may be","manufactured and used within a single","health institution without fulfilling the","requirements of this Regulation, provided","they comply with the conditions defined in","the first subparagraph, and the essential","requirements (Annex I), and applicable","harmonized standards (Article 6), and","applicable common technical","specifications (Article 7)."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"62","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-63","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 6 \u2013 subparagraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["Proportionate to the risk class and the type","of device, manufacturers of devices shall","institute and keep up to date a systematic","procedure to collect and review experience","gained from their devices placed on the","market or put into service, and to apply any","necessary corrective action, hereinafter","referred to as 'post-market surveillance","plan'. The post-market surveillance plan","shall set out the process for collecting,","recording, communicating to the","electronic system on vigilance referred in","Article 60 and investigating complaints and","reports from healthcare professionals,","patients or users on suspected incidents","related to a device, keeping a register of","non-conforming products and product","recalls or withdrawals, and if deemed","appropriate due to the nature of the device,","sample testing of marketed devices. Part of","the post-market surveillance plan shall be a","plan for post-market follow-up in","accordance with Part B of Annex XII.","Where post-market follow-up is not","deemed necessary, this shall be duly","justified and documented in the post-","market surveillance plan and subject to","approval by the competent authority."],"old":["Proportionate to the risk class and the type","of device, manufacturers of devices shall","institute and keep up to date a systematic","procedure to collect and review experience","gained from their devices placed on the","market or put into service, and to apply any","necessary corrective action, hereinafter","","","referred to as \u2018post-market surveillance","plan\u2019. The post-market surveillance plan","shall set out the process for collecting,","recording and investigating complaints and","reports from healthcare professionals,","patients or users on suspected incidents","related to a device, keeping a register of","non-conforming products and product","recalls or withdrawals, and if deemed","appropriate due to the nature of the device,","sample testing of marketed devices. Part of","the post-market surveillance plan shall be a","plan for post-market follow-up in","accordance with Part B of Annex XII.","Where post-market follow-up is not","deemed necessary, this shall be duly","justified and documented in the post-","market surveillance plan."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"63","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-64","location":[[" Proposal for a regulation","Article 8 \u2013 paragraph 7 \u2013 subparagraph 2"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:36"},"new":["For devices for self-testing or near-patient-","testing, the information supplied in","accordance with Section 17 of Annex I","shall be easily understandable and","provided in the language(s) of the Member","State where the device reaches its intended","user."],"old":["For devices for self-testing or near-patient-","testing, the information supplied in","accordance with Section 17 of Annex I","shall be provided in the language(s) of the","Member State where the device reaches its","intended user."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"64","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-65","location":[["Proposal for a regulation","Article 8 \u2013 paragraph 8"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:36"},"new":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","responsible national competent authority,","the distributors and, where applicable, the","authorised representative accordingly."],"old":["8. Manufacturers who consider or have","reason to believe that a device which they","have placed on the market is not in","conformity with this Regulation shall","immediately take the necessary corrective","action to bring that product into","conformity, withdraw it or recall it, as","appropriate. They shall inform the","distributors and, where applicable, the","authorised representative accordingly."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"65","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-66","justification":"Within the supply chain, distributors are responsible for product safety. Outside it,\nresponsibility for product safety and for completeness of documentation lies with the\nmanufacturer or importer.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:36"},"new":["Before making a device available on the","market for the first time, distributors shall","verify that the following requirements are","met:"],"old":["Before making a device available on the","market distributors shall verify that the","following requirements are met:"],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"66","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-67","justification":" Within the supply chain, distributors are responsible for product safety. Outside it,\n responsibility for product safety and for completeness of documentation lies with the\n manufacturer or importer.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point b"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:36"},"new":["(b) in the absence of a declaration of","conformity by the manufacturer or","importer, the product is accompanied by","the information to be supplied by the","manufacturer in accordance with Article","8(7);"],"old":["(b) the product is accompanied by the","information to be supplied by the","manufacturer in accordance with Article","8(7);"],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"67","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-68","justification":" Within the supply chain, distributors are responsible for product safety. Outside it,\n responsibility for product safety and for completeness of documentation lies with the\n manufacturer or importer.","location":[[" Proposal for a regulation","Article 12 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point c"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:36"},"new":["(c) the manufacturer and, where applicable,","the importer have complied with the","requirements set out in Article 11(3)."],"old":["(c) the manufacturer and, where applicable,","the importer have complied with the","requirements set out in Article 22 and","Article 11(3) respectively."],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"68","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-69","justification":"A distinction should be made between the various participants in the supply chain.","location":[["Proposal for a regulation","Article 12 \u2013 paragraph 4"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:36"},"new":["4. Distributors who consider or have reason","to believe that a device which they have","made available on the market is not in","conformity with this Regulation shall","immediately inform the manufacturer and,","where applicable, his authorised","representative and the importer and, within","their respective area of activity, make sure","that the necessary corrective action to bring","that device into conformity, withdraw or","recall it, if appropriate, is taken. Where the","device presents a risk, they shall also","immediately inform the competent","authorities of the Member States in which","they made the device available, giving","details, in particular, of the non-compliance","and of any corrective action taken."],"old":["4. Distributors who consider or have reason","to believe that a device which they have","made available on the market is not in","conformity with this Regulation shall","immediately inform the manufacturer and,","where applicable, his authorised","representative and the importer and make","sure that the necessary corrective action to","bring that device into conformity,","withdraw or recall it, if appropriate, is","taken. Where the device presents a risk,","they shall also immediately inform the","competent authorities of the Member States","in which they made the device available,","giving details, in particular, of the non-","compliance and of any corrective action","taken."],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"69","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Sirpa Pietik\u00e4inen","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-70","location":[["Proposal for a regulation","Article 15 \u2013 paragraph 1"]],"meps":[40599],"meta":{"created":"2019-07-03T05:35:36"},"new":["1. The EU declaration of conformity shall","state that fulfilment of the requirements","specified in this Regulation has been","demonstrated. It shall be continuously","updated. The minimum content of the EU","declaration of conformity is set out in","Annex III. It shall be issued in one of the","official Union languages."],"old":["1. The EU declaration of conformity shall","state that fulfilment of the requirements","specified in this Regulation has been","demonstrated. It shall be continuously","updated. The minimum content of the EU","","","declaration of conformity is set out in","Annex III. It shall be translated into the","official Union language or languages","required by the Member State(s) in which","the device is made available."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"70","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-71","location":[[" Proposal for a regulation","Article 22 \u2013 paragraph 8 \u2013 point b"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["(b) the legitimate interest in protecting","commercially sensitive information, to the","extent that it does not undermine public","health protection;"],"old":["(b) the legitimate interest in protecting","commercially sensitive information;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"71","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Anja Weisgerber","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-72","justification":" So that the process runs smoothly, it is important that traceability systems be technically\n compatible.","location":[[" Proposal for a regulation","Article 22 \u2013 paragraph 8 \u2013 point e a (new)"]],"meps":[28227],"meta":{"created":"2019-07-03T05:35:36"},"new":["(ea) compatibility with medical device","identification systems already on the","market."],"orig_lang":"de","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"72","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Nora Berra","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-73","location":[["Proposal for a regulation","Article 22 \u2013 paragraph 8 \u2013 point e a (new)"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:36"},"new":["(ea) compatibility with the other","traceability systems used by medical","device stakeholders."],"orig_lang":"fr","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"73","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-74","location":[["Proposal for a regulation","Article 24 \u2013 paragraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:36"},"new":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be made publicly","available and written in a way that is clear","to the intended user. The draft of this","summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"old":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be written in a way","that is clear to the intended user. The draft","of this summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"74","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-75","location":[["Proposal for a regulation","Article 24 \u2013 paragraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be written in a way","that is clear to the intended user. This","summary shall be accompanied by the","dataset collected during the clinical","investigation and the post-market clinical","follow-up. The draft of this summary shall","be part of the documentation to be","submitted to the notified body involved in","the conformity assessment in accordance","with Article 40 and shall be validated by","that body."],"old":["1. In the case of devices classified as class","C and D, other than devices for","performance evaluation, the manufacturer","shall draw up a summary of safety and","performance. It shall be written in a way","that is clear to the intended user. The draft","of this summary shall be part of the","documentation to be submitted to the","notified body involved in the conformity","assessment in accordance with Article 40","and shall be validated by that body."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"75","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-76","location":[[" Proposal for a regulation","Article 26 \u2013 paragraph 7"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["7. Member States shall provide the","Commission and the other Member States","with information on their procedures for","the assessment, designation and","notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto. Based","on this exchange of information and on","best practices established across Member","States, the Commission shall define,","within 2 years of the entry into force of","this Regulation, guidelines for the","procedures for the assessment,","designation and notification of conformity","assessment bodies and for the monitoring","of notified bodies to be carried out by","national authorities concerned."],"old":["7. Member States shall provide the","Commission and the other Member States","with information on their procedures for","the assessment, designation and","notification of conformity assessment","bodies and for the monitoring of notified","bodies, and of any changes thereto."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"76","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-77","location":[["Proposal for a regulation","Article 28 \u2013 paragraph 1 a (new)"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["1a. Subcontracting shall be limited to only","specific tasks connected with the","conformity assessment and the need to","subcontract such tasks shall be duly","justified to the national authority."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"77","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-78","location":[["Proposal for a regulation","Article 29 \u2013 paragraph 1 a (new)"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["1a. Any subsidiaries of the applicant","conformity assessment body which are","involved in the conformity assessment","process, in particular those located in","third countries, shall be subject to the","application for notification mechanism","and its assessment as described in Article","30."],"orig_lang":"pt","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"78","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-79","location":[["Proposal for a regulation","Article 35 \u2013 paragraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:36"},"new":["1. The Commission shall investigate all","cases where concerns have been brought to","its attention regarding the continued","fulfilment by a notified body of the","requirements set out in Annex VI or the","obligations to which it is subject. It may","also commence such investigations on its","own initiative, including the unannounced","inspection of the notified body by a joint","assessment team whose composition meets","the conditions set out in Article 30(3)."],"old":["1. The Commission shall investigate all","cases where concerns have been brought to","its attention regarding the continued","fulfilment by a notified body of the","requirements set out in Annex VI or the","obligations to which it is subject. It may","also commence such investigations on its","own initiative."],"orig_lang":"pt","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"79","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-80","location":[[" Proposal for a regulation","Article 40 \u2013 paragraph 9 \u2013 subparagraph 1 \u2013 introductory part"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["The Commission shall, by means of","implementing acts, specify the modalities","and the procedural aspects with a view to","ensuring harmonised application of the","conformity assessment procedures by the","notified bodies, for any of the following","aspects:"],"old":["The Commission may, by means of","implementing acts, specify the modalities","and the procedural aspects with a view to","ensuring harmonised application of the","conformity assessment procedures by the","notified bodies, for any of the following","aspects:"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"80","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-81","location":[[" Proposal for a regulation","Article 47 \u2013 paragraph 4"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["4. Where demonstration of conformity with","the general safety and performance","requirements based on clinical","performance data or parts thereof is not","deemed appropriate, adequate justification","for any such exception shall be given based","on the results of the manufacturer's risk","management and on consideration of the","characteristics of the device and, in","particular, its intended purpose(s), the","intended performance and the claims of the","manufacturer. The adequacy of","demonstration of conformity with the","general safety and performance","requirements based on the results of","analytical performance evaluation alone","shall be duly substantiated in the technical","documentation referred to in Annex II.","Exemption from demonstration of","conformity with general safety and","performance requirements based on","clinical data under the first subparagraph","shall be subject to prior approval by the","competent authority."],"old":["4. Where demonstration of conformity with","the general safety and performance","","requirements based on clinical","performance data or parts thereof is not","deemed appropriate, adequate justification","for any such exception shall be given based","on the results of the manufacturer's risk","management and on consideration of the","characteristics of the device and, in","particular, its intended purpose(s), the","intended performance and the claims of the","manufacturer. The adequacy of","demonstration of conformity with the","general safety and performance","requirements based on the results of","analytical performance evaluation alone","shall be duly substantiated in the technical","documentation referred to in Annex II."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"81","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-82","location":[["Proposal for a regulation","Article 47 \u2013 paragraph 5"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["5. The scientific validity data, the","analytical performance data and, where","applicable, the clinical performance data","shall be summarised as part of a clinical","evidence report referred to in Section 3 of","Part A of Annex XII. The clinical evidence","report shall be included in the technical","documentation referred to in Annex II","relating to the device concerned and be","made accessible to the public through the","electronic system referred to in Article 51","at the time the device is placed on the","market."],"old":["5. The scientific validity data, the","analytical performance data and, where","applicable, the clinical performance data","shall be summarised as part of a clinical","evidence report referred to in Section 3 of","Part A of Annex XII. The clinical evidence","report shall be included or fully referenced","in the technical documentation referred to","in Annex II relating to the device","concerned.","",""],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"82","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-83","location":[[" Proposal for a regulation","Article 48 \u2013 paragraph 4"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["4. All clinical performance studies shall be","designed and conducted in a way that the","rights, safety and well-being of the subjects","participating in such clinical performance","studies are protected and that the clinical","data generated in the clinical performance","study are going to be reliable and robust.","Realization of the clinical performance","studies shall be subject to a positive","opinion by the responsible Ethics","Committee."],"old":["4. All clinical performance studies shall be","designed and conducted in a way that the","rights, safety and well-being of the subjects","participating in such clinical performance","studies are protected and that the clinical","data generated in the clinical performance","study are going to be reliable and robust."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"83","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-84","location":[[" Proposal for a regulation","Article 49 \u2013 paragraph 6 \u2013 subparagraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["Member States shall ensure that the","assessment is done jointly by a reasonable","number of persons who collectively have","the necessary qualifications and","experience. In the assessment, the view of","at least one person whose primary area of","interest is non-scientific shall be taken into","account. The view of at least one patient","shall be taken into account. Realization of","the clinical performance studies shall be","subject to a positive opinion by the","responsible Ethics Committee."],"old":["Member States shall ensure that the","assessment is done jointly by a reasonable","number of persons who collectively have","the necessary qualifications and","experience. In the assessment, the view of","at least one person whose primary area of","interest is non-scientific shall be taken into","account. The view of at least one patient","shall be taken into account.",""],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"84","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-85","location":[["Proposal for a regulation","Article 51 \u2013 paragraph 1 \u2013 point a"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["(a) the registration of clinical performance","studies in accordance with Article 50 and","the clinical data generated;"],"old":["(a) the registration of clinical performance","studies in accordance with Article 50;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"85","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-86","location":[["Proposal for a regulation","Article 51 \u2013 paragraph 1 \u2013 point c"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["(c) the information related to clinical","performance studies conducted in more","than one Member State and the clinical","data generated in case of a single","application in accordance with Article 56;"],"old":["(c) the information related to clinical","performance studies conducted in more","than one Member State in case of a single","application in accordance with Article 56;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"86","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-87","justification":" For transparency and public health reasons. There is no reason to prevent access by\n independent academics to data on clinical performance and adverse events.","location":[["Proposal for a regulation","Article 51 \u2013 paragraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [...] of Regulation","(EU) No [Ref. of future Regulation on","clinical trials]. With the exception of the","information referred to in Article 50 and in","Article 51 (a), (c) and (d), the information","collated and processed in the electronic","system shall be accessible only to the","Member States and to the Commission."],"old":["2. When setting up the electronic system","referred in paragraph 1, the Commission","shall ensure that it is interoperable with the","EU database for clinical trials on medicinal","products for human use set up in","accordance with Article [\u2026] of Regulation","(EU) No [Ref. of future Regulation on","clinical trials]. With the exception of the","information referred to in Article 50, the","information collated and processed in the","electronic system shall be accessible only","to the Member States and to the","Commission."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"87","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-88","location":[[" Proposal for a regulation","Article 51 \u2013 paragraph 3"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["3. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 for determining the technical","requirements and parameters to allow","interoperability with the EU database for","clinical trials on medicinal products for","human use set up by Regulation (EU) No","[Ref. of future Regulation on clinical","trials]."],"old":["3. The Commission shall be empowered to","adopt delegated acts in accordance with","Article 85 determining which other","information regarding clinical","performance studies collated and","processed in the electronic system shall be","publicly accessible to allow","interoperability with the EU database for","clinical trials on medicinal products for","human use set up by Regulation (EU) No","[Ref. of future Regulation on clinical","trials]. Article 50(3) and (4) shall apply."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"88","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-89","location":[["Proposal for a regulation","Article 53 \u2013 paragraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["1. If the sponsor introduces modifications","to a clinical performance study that are","likely to have a substantial impact on the","safety or rights of the subjects or on the","robustness or reliability of the clinical data","generated by the study, he shall notify the","Member State(s) and the Ethics","Committee concerned of the reasons for","and the content of those modifications. The","notification shall be accompanied by an","updated version of the relevant","documentation referred to in Annex XIII."],"old":["1. If the sponsor introduces modifications","to a clinical performance study that are","likely to have a substantial impact on the","safety or rights of the subjects or on the","robustness or reliability of the clinical data","generated by the study, he shall notify the","Member State(s) concerned of the reasons","for and the content of those modifications.","The notification shall be accompanied by","an updated version of the relevant","documentation referred to in Annex XIII."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"89","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-90","justification":" Restricting the grounds for refusal as proposed in the original text would wrongly exclude aspects\n such as insufficiently relevant or robust data and other ethical considerations. Modifications to\n clinical investigations proposed by sponsors should not allow any reduction in scientific or ethical\n standards motivated by commercial interests.","location":[["Proposal for a regulation","Article 53 \u2013 paragraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["2. The sponsor may implement the","modifications referred to in paragraph 1 at","the earliest 30 days after notification,","unless the Member State concerned has","notified the sponsor of its duly justified","refusal."],"old":["2. The sponsor may implement the","modifications referred to in paragraph 1 at","the earliest 30 days after notification,","unless the Member State concerned has","notified the sponsor of its refusal based on","considerations of public health, patient","safety or public policy."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"90","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-91","location":[[" Proposal for a regulation","Article 54 \u2013 paragraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:37"},"new":["1. Where a Member State has refused,","suspended or terminated a clinical","performance study, or has called for a","substantial modification or temporary halt","of a clinical performance study, or has","been notified by the sponsor of the early","termination of a clinical performance study","on safety grounds, that Member State shall","communicate such facts and its decision","and the grounds therefore to all Member","States and the Commission by means of the","electronic system referred to in Article 51."],"old":["1. Where a Member State has refused,","suspended or terminated a clinical","performance study, or has called for a","substantial modification or temporary halt","of a clinical performance study, or has","been notified by the sponsor of the early","termination of a clinical performance study","on safety grounds, that Member State shall","communicate its decision and the grounds","therefore to all Member States and the","Commission by means of the electronic","system referred to in Article 51."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"91","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-92","justification":"Such data is already available to the sponsor and shall be communicated to the Member State\nfor adequate statistical scrutiny.","location":[[" Proposal for a regulation","Article 55 \u2013 paragraph 3"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["3. Within one year from the end of the","clinical performance study, the sponsor","shall submit to the Member States","concerned a summary of the results of the","clinical performance study in form of a","clinical performance study report referred","to in Section 2.3.3 of Part A of Annex XII","together with all the data collected during","the clinical performance study, including","negative findings. Where, for scientific","reasons, it is not possible to submit the","clinical performance study report within","one year, it shall be submitted as soon as it","is available. In this case, the clinical","performance study protocol referred to in","Section 2.3.2 of Part A of Annex XII shall","specify when the results of the clinical","performance study are going to be","submitted, together with an explanation."],"old":["3. Within one year from the end of the","clinical performance study, the sponsor","shall submit to the Member States","concerned a summary of the results of the","clinical performance study in form of a","clinical performance study report referred","to in Section 2.3.3 of Part A of Annex XII.","","Where, for scientific reasons, it is not","possible to submit the clinical performance","study report within one year, it shall be","submitted as soon as it is available. In this","case, the clinical performance study","protocol referred to in Section 2.3.2 of Part","A of Annex XII shall specify when the","results of the clinical performance study","are going to be submitted, together with an","explanation."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"92","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-93","justification":" The solution proposed by the Commission text allows sponsors to cherry pick the competent\n authorities applying less stringent standards, those less resourced or overburdened with high\n number of requests which aggravates the proposed tacit approval of clinical investigations. A\n framework for deciding on the coordinating Member State can be set up by the already\n proposed MDCG, in line with its tasks described in Article 80.","location":[["Proposal for a regulation","Article 56 \u2013 paragraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["2. Concerned Member States shall agree,","within six days of submission of the single","application, which Member State shall be","the coordinating Member State. Member","States and the Commission shall agree, in","the framework of the attributions of the","Medical Devices Coordination Group, on","clear rules for designating the","coordinating Member State."],"old":["2. In the single application, the sponsor","shall propose one of the Member States","concerned as coordinating Member State.","If that Member State does not wish to be","the coordinating Member State, it shall","agree, within six days of submission of the","single application, with another Member","State concerned that the latter shall be the","coordinating Member State. If no other","Member State accepts to be the","coordinating Member State, the Member","State proposed by the sponsor shall be the","coordinating Member State. If another","Member State than the one proposed by","the sponsor becomes coordinating Member","State, the deadlines referred to in Article","49(2) shall start on the day following the","","acceptance."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"93","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-94","location":[[" Proposal for a regulation","Article 57 \u2013 paragraph 1 \u2013 introductory part"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["1. The sponsor shall fully record and","register in the electronic system on","clinical investigations referred to in","Article 51, any of the following:"],"old":["1. The sponsor shall fully record any of the","following:"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"94","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-95","location":[[" Proposal for a regulation","Article 57 \u2013 paragraph 2 \u2013 subparagraph 1 \u2013 point a"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:38"},"new":["(a) any adverse event that has a causal","relationship with the device for","performance evaluation, the comparator or","the study procedure or where such causal","relationship is reasonably possible;"],"old":["(a) a serious adverse event that has a","causal relationship with the device for","performance evaluation, the comparator or","the study procedure or where such causal","relationship is reasonably possible;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"95","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-96","location":[["Proposal for a regulation","Article 57 \u2013 paragraph 4 \u2013 subparagraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["In the case of a clinical investigation for","which the sponsor has used the single","application referred to in Article 56, the","sponsor shall report any event as referred","to in paragraphs 1 and 2 by means of the","electronic system referred to in Article 51.","Upon receipt, this report shall be","transmitted electronically to all Member","States concerned."],"old":["In the case of a clinical performance study","for which the sponsor has used the single","application referred to in Article 56, the","sponsor shall report any event as referred","to in paragraph 2 by means of the","electronic system referred to in Article 51.","Upon receipt, this report shall be","transmitted electronically to all Member","States concerned."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"96","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-97","location":[["Proposal for a regulation","Article 59 \u2013 paragraph 1 \u2013 subparagraph 1 \u2013 point a"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:38"},"new":["(a) any incident in respect of devices made","available on the Union market;"],"old":["(a) any serious incident in respect of","devices made available on the Union","market;"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"97","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-98","justification":" High quality registries for broad populations will avoid fragmentation of registries and will\n enable a more adequate picture of safety and efficacy of medical devices.","location":[["Proposal for a regulation","Article 59 \u2013 paragraph 3 a (new)"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["3a. Member States and the Commission","shall develop and guarantee the","interoperability between national records","and the electronic system on vigilance","referred to in Article 60, to ensure the","automated export of data to this system,","while avoiding duplication of registries."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"98","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Nora Berra","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-99","location":[[" Proposal for a regulation","Article 59 \u2013 paragraph 3 \u2013 subparagraph 1"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:38"},"new":["The Member States shall take all","appropriate measures to encourage","healthcare professionals, including","pharmacists, users and patients to report to","their competent authorities suspected","serious incidents referred to in point (a) of","paragraph 1. They shall record such reports","centrally at national level. Where a","competent authority of a Member State","obtains such reports, it shall take the","necessary steps to ensure that the","manufacturer of the device concerned is","informed of the incident. The manufacturer","shall ensure the appropriate follow-up."],"old":["The Member States shall take all","appropriate measures to encourage","healthcare professionals, users and patients","to report to their competent authorities","suspected serious incidents referred to in","point (a) of paragraph 1. They shall record","such reports centrally at national level.","Where a competent authority of a Member","State obtains such reports, it shall take the","necessary steps to ensure that the","manufacturer of the device concerned is","informed of the incident. The manufacturer","shall ensure the appropriate follow-up."],"orig_lang":"fr","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"99","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-100","justification":"Access to clinical data is essential to preserve system\u2019s transparency and for analysis by\nindependent academics and professional medical organizations. No intellectual property or\ncommercially sensitive information is implicated in such clinical data.","location":[["Proposal for a regulation","Article 60 \u2013 paragraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["2. The information collated and processed","by the electronic system shall be accessible","to the competent authorities of the Member","States, to the Commission, to the notified","bodies and without prejudice to the","preservation of intellectual property, to","healthcare professionals and the public.","The data referred to in points (a) to (e) of","Article 60(1) shall not be considered","commercially confidential information."],"old":["2. The information collated and processed","by the electronic system shall be accessible","to the competent authorities of the Member","States, to the Commission and to the","notified bodies."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"100","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-101","justification":"The adequate level of information should be established in the present Regulation","location":[["Proposal for a regulation","Article 60 \u2013 paragraph 3"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["deleted"],"old":["3. The Commission shall ensure that","healthcare professionals and the public","have appropriate levels of access to the","electronic system."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"101","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Antonyia Parvanova","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-102","location":[[" Proposal for a regulation","Article 83 \u2013 paragraph 1"]],"meps":[34234],"meta":{"created":"2019-07-03T05:35:38"},"new":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","necessary to ensure that they are","implemented and sufficiently dissuasive.","The penalties provided for shall be","effective, proportionate, and dissuasive.","The Member States shall notify those","provisions to the Commission by [3","months prior to the date of application of","this Regulation] and shall notify it without","delay of any subsequent amendment","affecting them."],"old":["The Member States shall lay down the","provisions on penalties applicable for","infringement of the provisions of this","Regulation and shall take all measures","necessary to ensure that they are","implemented. The penalties provided for","shall be effective, proportionate, and","dissuasive. The Member States shall notify","those provisions to the Commission by [3","months prior to the date of application of","this Regulation] and shall notify it without","delay of any subsequent amendment","affecting them."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"102","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-103","location":[[" Proposal for a regulation","Article 90 \u2013 paragraph 2"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["2. It shall apply from [three years after","entry into force]."],"old":["2. It shall apply from [five years after entry","into force]."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"103","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-104","location":[["Proposal for a regulation","Annex 5 \u2013 section 1 \u2013 paragraph 1 \u2013 point 15"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:38"},"new":["15. in case of devices classified as class C","or D, the summary of safety and","performance, and the full dataset collected","during the clinical study and the post-","market clinical follow-up."],"old":["15. in case of devices classified as class C","or D, the summary of safety and","performance,"],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"104","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-105","location":[["Proposal for a regulation","Annex 8 \u2013 section 1 \u2013 point 4 \u2013 point 4.4 \u2013 introductory part"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:39"},"new":["4.4. 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This leaves ample room for interpretation and,\n while the notified body is under no obligation to follow the EMA\u2019s opinion, it seems rather\n unlikely that they disregard it. We thus need a definition of what happens if the assessments of\n the EMA and notified body are inconsistent.","location":[["Proposal for a regulation","Annex 8 \u2013 section 2 \u2013 point 6 \u2013 point 6.2 \u2013 point e"]],"meps":[96947],"meta":{"created":"2019-07-03T05:35:39"},"new":["(e) The notified body shall give due","consideration to the opinion, if any,","expressed by the medicinal products","competent authority concerned or the EMA","when making its decision. If the notified","body deviates from that position, it shall","justify its final decision to the medicinal","products competent authority concerned or","to the EMA. 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The design-examination certificate","shall be delivered in accordance with point","(d) of Section 6.1."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"106","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-107","justification":" For adequate scrutiny; the dataset already exists and represents no further burden.","location":[[" Proposal for a regulation","Annex 12 \u2013 section 1 \u2013 point 1 \u2013 point 1.2.1 \u2013 point 1.2.1.4"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:39"},"new":["1.2.1.4 The analytical performance full","dataset shall accompany the clinical","evidence report and may be summarised as","part of it."],"old":["1.2.1.4 The analytical performance data","shall be summarised as part of the clinical","evidence 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in Annex VII,","the clinical performance study report shall","include the method of data analysis, the","study conclusion, the relevant details of the","study protocol and the individual data","points."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"110","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":" Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-111","location":[[" Proposal for a regulation","Annex 12 \u2013 section 1 \u2013 point 2 \u2013 point 2.2 \u2013 paragraph 1"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:39"},"new":["Every step in the clinical performance","study, from first consideration of the need","and justification of the study to the","publication of the results, shall be carried","out in accordance with recognised ethical","principles, as for example those laid 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The","results and conclusions shall be","transparent, free of bias and clinically","relevant. The report shall contain sufficient","information to enable it to be understood","by an independent party without reference","to other documents. The report shall also","include as appropriate any protocol","amendments or deviations, and data","exclusions with the appropriate rationale."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"112","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"},{"authors":"Ant\u00f3nio Fernando Correia de Campos","changes":{},"committee":["IMCO"],"date":"2013-05-07T00:00:00","id":"PE510.668-113","location":[["Proposal for a regulation","Annex 12 \u2013 section 1 \u2013 point 3 \u2013 point 3.3"]],"meps":[96975],"meta":{"created":"2019-07-03T05:35:39"},"new":["3.3 The clinical evidence data and its","documentation shall be updated throughout","the life cycle of the device concerned with","data obtained from the implementation of","the manufacturer's post-market surveillance","plan referred to in Article 8(5) which shall","include a plan for the device post-market","follow-up in accordance with Part B of this","Annex. The clinical evidence data and its","subsequent updates through post-market","follow-up shall be accessible to the public","through the electronic systems referred to","in Art. 51 and Art. 60."],"old":["3.3 The clinical evidence and its","documentation shall be updated throughout","the life cycle of the device concerned with","data obtained from the implementation of","the manufacturer's post-market surveillance","plan referred to in Article 8(5) which shall","include a plan for the device post-market","follow-up in accordance with Part B of this","","Annex."],"orig_lang":"en","peid":"PE510.668v01-00","reference":"2012/0267(COD)","seq":"113","src":"http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-510.668+01+DOC+PDF+V0//EN&language=EN"}],"changes":{"2012-10-08T23:59:24":[{"data":[{"body":"EP","date":"2012-09-26T00:00:00","type":"EP officialisation"},{"body":"EC","commission":[{"Commissioner":"DALLI John","DG":{"title":"Health and Consumers","url":"http://ec.europa.eu/dgs/health_consumer/index_en.htm"}}],"date":"2012-09-26T00:00:00","docs":[{"celexid":"CELEX:52012PC0541:EN","title":"COM(2012)0541","type":"Legislative proposal published","url":"http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=2012&nu_doc=541"},{"title":"SWD(2012)0273","type":"Document attached to the procedure","url":"http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0273:FIN:EN:PDF"},{"title":"SWD(2012)0274","type":"Document attached to the procedure","url":"http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=SWD:2012:0274:FIN:EN:PDF"}],"type":"Legislative proposal"}],"path":["activities"],"type":"added"},{"data":[{"body":"EC","commissioner":"DALLI John","dg":{"title":"Health and Consumers","url":"http://ec.europa.eu/dgs/health_consumer/index_en.htm"}}],"path":["other"],"type":"added"},{"data":[{"body":"EP","committee":"ENVI","committee_full":"Environment, Public Health and Food Safety","responsible":true},{"body":"EP","committee":"IMCO","committee_full":"Internal Market and Consumer Protection","responsible":false},{"body":"EP","committee":"INTA","committee_full":"International Trade","responsible":false},{"body":"EP","committee":"ITRE","committee_full":"Industry, Research and Energy","responsible":false}],"path":["committees"],"type":"added"},{"data":{"European Commission":{"title":"PreLex","url":"http://ec.europa.eu/prelex/liste_resultats.cfm?CL=en&ReqId=0&DocType=COD&DocYear=2012&DocNum=0267"},"National parliaments":{"title":"IPEX","url":"http://www.ipex.eu/IPEXL-WEB/dossier/dossier.do?code=COD&year=2012&number=0267&appLng=EN"}},"path":["links"],"type":"added"},{"data":{"instrument":"Regulation","legal_basis":["Treaty on the Functioning of the EU TFEU 114-p1","Treaty on the Functioning of the EU TFEU 168-p4"],"reference":"2012/0267(COD)","stage_reached":"Preparatory phase in Parliament","subject":["2.10.03 Standardisation, EC standards and trade-mark, certification, compliance","2.80 Cooperation between administrations","3.40.11 Precision engineering, optics, photography, medical","4.20 Public health","4.20.02.06 Clinical practice and experiments","4.20.05 Health legislation and policy","4.60.02 Consumer information, publicity, labelling","4.60.08 Safety of products and services, product liability","6.20.02 Export/import control, trade defence"],"subtype":"Legislation","summary":["Repealing Directive 98/79/EC","See also"],"title":"In vitro diagnostic medical devices","type":"COD - 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This Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Peter LIESE (EPP, DE) the\nproposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe committee recommends that the position of\nParliament adopted in first reading following the ordinary\nlegislative procedure should amend the Commission proposal as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices. These parts have been assessed together\nin the two reports. The amendments cover, for example, the role,\nthe structure and the necessary improvement of the notified bodies,\nthe surveillance system, the joint assessment, the scrutiny,\nidentification and traceability and the role of the Medical Device\nCoordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work.
\nNotified bodies shall have permanent \"in house\"\ncompetent personnel and expertise.
\nThe notified body shall publish a list of its staff\nresponsible for the conformity assessment and certification of\nmedical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nThe report also made improvements to the Commission\nproposal on the following point :
\nEthics committee:\n the clinical performance study should be positively assessed\nby an independent ethics committee before it starts. The\ntime limits are slightly extended to give the ethics\ncommittee and the authorities the time necessary to assess the\nproposal.
\nGenetic test: a device\nmay only be used for the purpose of a genetic test after the person\nconcerned has given free and informed consent to it. The person\nconcerned must receive appropriate information on the nature, the\nsignificance and the implications of the genetic test before the\ndevice is used.
\nGenetic counselling:\nappropriate genetic counselling shall be mandatory before\nusing a device for the purpose of predictive and prenatal testing\nand after a genetic condition has been diagnosed. Such\ncounselling shall include medical, ethical, social, psychological\nand legal aspects and shall be carried out by\nphysicians qualified in genetic counselling.
\nConsent: a device may\nonly be used for the purpose of a genetic test after the person\nconcerned has given free and informed consent to it. The consent\nhas to be given explicitly and in writing. It can be revoked at any\ntime in writing or orally.
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nScope: the amended text\nstates that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nCompanion diagnostic means a device\nspecifically intended for and\nessential to the selection of patients with a\npreviously diagnosed condition or predisposition as suitable\nor unsuitable for a specific therapy with\na medicinal product or a range of medicinal products.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the\nRegulation: Members propose that the\nRegulation should be applicable three years after its entry\ninto force, whereas the Commission had proposed five\nyears.
\nThe European Parliament adopted amendments to\nthe proposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe issue has been referred back to the committee\nresponsible. The vote has been postponed.
\nThe main amendments adopted in plenary were as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices.
\nAs for the abovementioned proposal, the amendments\ncover, for example, the role, the structure and the necessary\nimprovement of the notified bodies, the surveillance system, the\nsetting up of a Medical Device Advisory Committee, the obligation\nof manufacturers to take liability insurance with sufficient\nminimum coverage, the joint assessment, the scrutiny,\nidentification and traceability, improved access to information for\nthe general public and healthcare professionals and the role of the\nMedical Device Coordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work. Notified bodies shall have permanent \"in house\"\ncompetent personnel and expertise. The notified body shall publish\na list of its staff responsible for the conformity assessment and\ncertification of medical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nParliament also made improvements to the Commission\nproposal on the following points:
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNo incentives or financial inducements are given\nexcept compensation for participation in the clinical performance\nstudy.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nAdvisory Committee:\nParliament called for a multidisciplinary Medical Device Advisory\nCommittee (MDAC) to be set up which should be composed of experts\nand representatives of the relevant stakeholders should be set up\nto provide scientific advice to the Commission, the Medical Device\nCoordination Group (MDCG) and Member States on issues of medical\ntechnology, regulatory status of devices and other aspects of\nimplementation of this Regulation as necessary.
\nScope: the amended text\nstated that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nDirect to consumer advertising of devices classed as prescription only by this\nRegulation shall be illegal.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the Regulation: Members proposed that the Regulation should be\napplicable three years after its entry into force, whereas\nthe Commission had proposed five years.
\nThe European Parliament adopted amendments to\nthe proposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe issue has been referred back to the committee\nresponsible. The vote has been postponed.
\nThe main amendments adopted in plenary were as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices.
\nAs for the abovementioned proposal, the amendments\ncover, for example, the role, the structure and the necessary\nimprovement of the notified bodies, the surveillance system, the\nsetting up of a Medical Device Advisory Committee, the obligation\nof manufacturers to take liability insurance with sufficient\nminimum coverage, the joint assessment, the scrutiny,\nidentification and traceability, improved access to information for\nthe general public and healthcare professionals and the role of the\nMedical Device Coordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work. Notified bodies shall have permanent \"in house\"\ncompetent personnel and expertise. The notified body shall publish\na list of its staff responsible for the conformity assessment and\ncertification of medical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nParliament also made improvements to the Commission\nproposal on the following points:
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNo incentives or financial inducements are given\nexcept compensation for participation in the clinical performance\nstudy.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nAdvisory Committee:\nParliament called for a multidisciplinary Medical Device Advisory\nCommittee (MDAC) to be set up which should be composed of experts\nand representatives of the relevant stakeholders should be set up\nto provide scientific advice to the Commission, the Medical Device\nCoordination Group (MDCG) and Member States on issues of medical\ntechnology, regulatory status of devices and other aspects of\nimplementation of this Regulation as necessary.
\nScope: the amended text\nstated that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nDirect to consumer advertising of devices classed as prescription only by this\nRegulation shall be illegal.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the Regulation: Members proposed that the Regulation should be\napplicable three years after its entry into force, whereas\nthe Commission had proposed five years.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThe European Parliament adopted amendments to\nthe proposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe issue has been referred back to the committee\nresponsible. The vote has been postponed.
\nThe main amendments adopted in plenary were as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices.
\nAs for the abovementioned proposal, the amendments\ncover, for example, the role, the structure and the necessary\nimprovement of the notified bodies, the surveillance system, the\nsetting up of a Medical Device Advisory Committee, the obligation\nof manufacturers to take liability insurance with sufficient\nminimum coverage, the joint assessment, the scrutiny,\nidentification and traceability, improved access to information for\nthe general public and healthcare professionals and the role of the\nMedical Device Coordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work. Notified bodies shall have permanent \"in house\"\ncompetent personnel and expertise. The notified body shall publish\na list of its staff responsible for the conformity assessment and\ncertification of medical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nParliament also made improvements to the Commission\nproposal on the following points:
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNo incentives or financial inducements are given\nexcept compensation for participation in the clinical performance\nstudy.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nAdvisory Committee:\nParliament called for a multidisciplinary Medical Device Advisory\nCommittee (MDAC) to be set up which should be composed of experts\nand representatives of the relevant stakeholders should be set up\nto provide scientific advice to the Commission, the Medical Device\nCoordination Group (MDCG) and Member States on issues of medical\ntechnology, regulatory status of devices and other aspects of\nimplementation of this Regulation as necessary.
\nScope: the amended text\nstated that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nDirect to consumer advertising of devices classed as prescription only by this\nRegulation shall be illegal.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the Regulation: Members proposed that the Regulation should be\napplicable three years after its entry into force, whereas\nthe Commission had proposed five years.
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThis Communication, together with the proposal to\nrevise the legislation on medical devices and the proposal on in vitro diagnostic medical\ndevices, constitute a response\nto the Council Conclusions on innovation in the medical device\nsector adopted on 6 June 2011 and to the European Parliament\nResolution on defective silicone breast\nimplants adopted in June 2012\n. Both the Council and the European Parliament have pointed to the\nnecessity of adapting the medical device legislation with the aim\nto achieve a suitable, robust, transparent and sustainable\nregulatory framework. Such framework should be central to fostering\nthe development of safe, effective and innovative medical devices\nand in vitro diagnostic medical devices, for the benefit of\nEuropean patients, consumers and healthcare\nprofessionals.
\nIt is estimated that, in 2060, there will be twice as\nmany Europeans aged 65 or over (152.6 million in 2060 compared to\n87.5 million in 2010). An ageing population and changes in\nlifestyle will lead to an important evolution in disease patterns,\nwith an increasing prevalence of chronic, and often multiple,\ndiseases, such as cancer, diabetes, heart diseases, respiratory\nconditions, stroke, dementia and depression. In 2010, over\none-third of Europes population was estimated to have\ndeveloped at least one chronic disease.
\nIn this evolving and challenging context, medical\ndevices and in vitro diagnostic medical devices will be of\nincreasing importance to public health and medical care.
\nThe need for a safe, transparent and sustainable\nlegislation: appropriate legislation\nis fundamental to ensuring health protection and effective\ninnovation and will:
\n\n· \ngive patients, consumers and healthcare\nprofessionals confidence in the devices they might use every\nday;
\n\n· \nallow industry to bring safe, effective and\ninnovative products to market quickly and efficiently;
\n\n· \nincrease the ability of innovative companies to\nattract investors, estimate costs and anticipate\nprocedures.
\nThe need to restore patients', consumers' and\nhealthcare professionals' confidence:\nin an internal market of 32 participating countries, important\ndifferences in interpreting and applying the rules have emerged,\nthus undermining the legislation's main objectives the\nsafety of devices and their free circulation within the internal\nmarket. Moreover, there are regulatory gaps or uncertainties with\nregard to certain products. The regulatory system has also suffered\nfrom a lack of transparency and shortcomings in its\nimplementation, in particular in the fields of market\nsurveillance, vigilance and the functioning of notified\nbodies.
\nIn addition, recent serious incidents involving\nmedical implants (e.g. breast implants, metal-on-metal hip\nreplacements) have put patient safety at risk and revealed further\nshortcomings of the current legislation, especially with regard to\npost-market controls.
\nThe proposed Regulations will:
\n\n· \namend and clarify the scope of the legislation,\nto take into account scientific and technological progress and\nrespond to tomorrow's needs. It is extended to include, for\nexample, implants for aesthetic purposes and clarified as regards\ngenetic tests;
\n\n· \nstrenghten the supervision of the notified\nbodies by the Member States, in order to ensure that all bodies\nhave the necessary competence to carry out the pre-market\nassessment of devices;
\n\n· \nguarantee the independency and the quality of\npre-market assessment of devices, by clarifying and enhancing the\nposition and powers of notified bodies vis-à-vis the\nmanufacturers (e.g. regular checks on manufacturers, including\nunannounced factory inspections) and by providing an appropriate\nlevel of intervention of public authorities;
\n\n· \nclarify the obligations and responsibilities of\nmanufacturers, importers and distributors. This encompasses diagnostic services, internet sales\nand parallel trade;
\n\n· \nensure transparency, in particular through an\nexpanded European database on medical devices and in vitro\ndiagnostic medical devices partially accessible to the public. It\nwill provide patients, healthcare professionals and the public at\nlarge with comprehensive information on products available on the\nEU market, enabling them to make better informed\ndecisions;
\n\n· \nincrease devices traceability throughout the\nsupply chain, by requiring that manufacturers, on a risk-based\napproach, fit their devices with a Unique Device Identifier (UDI).\nThis will allow fast and effective measures in case of safety\nproblems;
\n\n· \nreinforce the rules governing clinical\nevaluation throughout the life of medical devices and in vitro\ndiagnostic medical devices, to ensure patient and consumer\nsafety;
\n\n· \nstrengthen the provisions governing market\nsurveillance and vigilance, allowing better coordination between\nauthorities to ensure rapid and consistent responses to safety\nissues;
\n\n· \nmake the management of the system more robust\nthrough mechanisms of effective coordination between authorities,\nwith scientific support by the Commission, in order to ensure a\nuniform and sustainable implementation of the future\nRegulations.
\nThe medical device and the in vitro diagnostic medical\ndevices sectors are estimated to comprise more than 500,000\nproducts. They contribute substantially to the EUs balance of\ntrade, employ more than 500,000 people in about 25,000 companies,\n80 % of medical devices companies and 95% of in vitro diagnostic\nmedical devices companies being small to medium-sized or micro\nenterprises. In 2009, they generated annual sales of around EUR 95\nbillion (EUR 85 billion for medical devices and EUR 10 billion for\nin vitro diagnostic medical devices) in the European (EU/EFTA)\nmarket. Last but not least, they are sectors that invest heavily in\nresearch and development, as about 6-8 % of medical devices annual\nsales and 10% of in vitro diagnostic medical devices annual sales\nare ploughed back into research each year, equivalent respectively\nto some EUR 6.5 billion and some EUR 1 billion, usually through\ncollaboration with healthcare professionals and\nacademia.
\nIt is estimated that the establishment of a central\nregistration tool would help reducing the administrative costs\nby up to EUR 157million. Also an EU vigilance portal with\ncentral reporting of serious incidents instead of multiple\nreporting is expected to bring about non negligible reductions in\nadministrative costs.
\nHealth is a clear determinant of economic growth. In\nthis context, innovation in the medical device and in vitro\ndiagnostic medical device areas occupies a central place in\ninitiatives falling in the framework of the Europe 2020 Strategy,\nin particular under the Innovation\nUnion and the Digital\nAgenda for Europe flagship initiatives.
\nThe proposed Regulations have the objective of\nbringing these two aspects together and are an essential\npush factor for fostering an EU of active and healthy\ncitizens.
\nThe European Parliament adopted by 492 to 21, with 117\nabstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council on in\nvitro diagnostic medical devices.
\nThe report was sent back to the committee at the 22\nOctober 2013 plenary sitting.
\nParliament adopted as its position at first reading\nthe text adopted on 22 October 2013 (please refer to the summary of that\ndate).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThe Council took note of a presidency progress report on two draft regulations on medical devices and on in vitro diagnostic medical devices.
Ministers provided guidance for future work on these files as regards the three following elements:
(1) The designation of conformity assessment bodies as notified bodies and the monitoring of these bodies: most Member States supported the idea of further clarifying the procedures for designating notified bodies and strengthening cooperation between Member States to ensure that notified bodies meet similar standards throughout the EU. But they also warned against increasing the administrative burden unnecessarily.
(2) The reporting of incidents, market surveillance and corrective measures: all Member States supported strengthened requirements on post-market surveillance and responsibility for follow-up by manufacturers, e.g. by collecting and analysing data on the performance of medical devices, in particular on adverse reactions in which they are involved.
However, as regards the balance between controls before and after placing devices on the market there were diverging views.
(3) The role and tasks of the medical device coordination group (MDCG): all delegations support the establishment of the MDCG. Most delegations support the idea to unify co-operation between Member States regarding medical devices and in vitro diagnostic medical devices by appointing one representative per Member State in the Medical Device Coordination Group (MDCG) rather than separate representatives for medical devices and in vitro diagnostic medical devices. There is broad agreement that the establishment of a network of reference laboratories is important for the proper evaluation of in vitro diagnostic medical devices.
As regards the evaluation of medical devices, however, many delegations have expressed an interest in either complementing the reference laboratories with device panels or replacing them entirely with device panels in order to provide relevant expertise input for regulatory measures.
Overall, many Member States stressed the need to develop a consistent legislative package that guarantees patient safety and facilitates innovation in order to improve treatments, decrease costs for patients and taxpayers, and preserve the competitiveness of the EU industry.
The Council instructed its preparatory bodies to continue examining the two files with a view to agreeing a Council position in the autumn. \n\t\t \t\t\t\t\t\t
The Council took note of a presidency progress\nreport on two draft regulations on medical devices and in\nvitro diagnostic medical devices.
\nThe report noted that considerable progress has been\nachieved on these files under the Italian presidency. However,\nfurther discussions are needed for the Council to agree its\nposition.
\nOutstanding issues include:
\nThe Presidency is satisfied to have contributed to the\nprogress of the work and intends to compile complete texts for\nboth proposals by the end of its tenancy.
\nThe Council adopted its position at first reading with\na view to the adoption of a Regulation of the European Parliament\nand of the Council on in-vitro diagnostic medical devices\nwhich replaces Council Directive 98/79/EC and Commission Decision\n2010/227/EU.
\nThe proposed Regulation aims to put in place a robust,\ntransparent and sustainable regulatory framework for in\nvitro diagnostic medical devices for human use in the\nEuropean Union (e.g. HIV blood tests, pregnancy tests, blood sugar\nmonitoring systems for diabetics). It shall apply to performance\nstudies concerning such in vitro diagnostic medical devices and\naccessories conducted in the Union.
\nIts objective is to enhance patient safety by:\n(i) introducing more stringent procedures for conformity assessment\nand for post-marketing surveillance, and (ii) requiring\nmanufacturers to produce clinical safety data, performance and\nunknown side-effects.
\nNotified bodies: the\nCouncil position strengthens the rules regarding notified bodies in\norder to ascertain that notified bodies are designated and operate\nunder harmonised conditions throughout the Union. These rules\nprovide a stronger mandate to independent notified bodies in their\nassessment of in vitro diagnostic medical devices before\nthey can be placed on the market.
\nAvailability of clinical data: the requirements on collection of data in clinical\ninvestigations on medical devices and performance studies on in\nvitro diagnostic medical devices have been considerably\nstrengthened and aligned to those applicable for clinical trials on\nmedicinal products for human use, particularly as regards\nprovisions on informed consent and protection of vulnerable\nsubjects.
\nThe Councils position sets out the verification\nby a designated reference laboratory of the performance claimed by\nmanufacturers and a consultation with an expert panel as regards\nthe evaluation for certain high-risk devices.
\nInformation and counselling for genetic\ntesting: Member States shall\nensure that where a genetic test is used on individuals in the\ncontext of healthcare, the subject to the testing must be provided\nwith relevant information on the nature, significance and\nimplications of the test, as appropriate. In particular, there\nshould be appropriate access to counselling where genetic testing\nprovides information on diseases that are considered to be\nuntreatable.
\nLiability:\nmanufacturers' responsibilities are clearly set out for the\nfollow-up of the quality, performance and safety of devices\nplaced on the market. The Council requested that manufacturers\nshould put in place measures to provide sufficient financial\ncoverage in respect of their potential liability under\nDirective 85/374/EEC concerning liability for defective\nproducts.
\nThe authorised representative would be jointly\nand severally liable with the importer and manufacturer in case of\ndamages suffered due to defective devices.
\nIdentification and traceability related\nobligations: the Councils\nposition sets out detailed rules for the implementation of the\nUnique Device Identification (UDI) system. The main features of the\nposition are the requirement for manufacturers to have the UDI code\nassigned to their devices by the date of application and the\nrequirement for the UDI carrier to be placed on the device and all\nhigher levels of packaging gradually depending on the risk class of\nthe device.
\nClassification: the\nclassification system for medical devices, and, even further, the\nclassification system for in vitro diagnostic medical\ndevices have been adapted to correspond to the rapid increase in\nscientific, medical and technical knowledge and to the resulting\ndevelopment of more and more advanced device.
\nEuropean Medical Devices Database\n(EUDAMED): the proposed Regulation\nensures greater transparency of information on devices\nplaced on the market by setting up a central database to provide\npatients, healthcare professionals and the public with\ncomprehensive information on products available in the\nEU.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the recommendation for second reading contained\nin the report by Peter LIESE (EPP, DE) on the Council position at\nfirst reading with a view to the adoption of a regulation of the\nEuropean Parliament and of the Council on in vitro diagnostic\nmedical devices and repealing Directive 98/79/EC and Commission\nDecision 2010/227/EU.
\nThe committee recommended the European Parliament to\napprove the Council position at first reading without\namendments. It also took note of two Commission statements\nannexed to the draft legislative resolution.
\nThe Commission:
\nCouncils first reading position is in conformity\nwith the agreement reached during the interinstitutional\nnegotiations. The report is accompanied by a short justification\nwhich focuses on the following elements of the approved\ntext:
\nThe European Parliament adopted a legislative\nresolution on the Council position at first reading with a view to\nthe adoption of a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices and repealing\nDirective 98/79/EC and Commission Decision 2010/227/EU.
\nA proposal to reject the Council proposal, submitted\nby the EFDD group, was rejected in plenary by 59 votes to 635, with\n9 abstentions.
\nIn line with the recommendation for second reading by\nits Committee on the Environment, Public Health and Food Safety,\nParliament approved the Council position at first reading\nwithout amendments.
\nThe proposed Regulation seeks to harmonise the rules\nfor the placing on the market and putting into service of in vitro\ndiagnostic medical devices (e.g. HIV blood tests, pregnancy tests,\nblood sugar monitoring systems for diabetics) and their accessories\non the Union market which may then benefit from the principle of\nfree movement of goods.
\nParliament took note of two Commission\nstatements annexed to the legislative resolution. With these\nstatements, the Commission:
\nPURPOSE: to propose a new legislative framework for in\nvitro diagnostic medical devices.
\nPROPOSED ACT: Regulation of the European Parliament\nand of the Council.
\nBACKGROUND: the current EU regulatory framework for in\nvitro diagnostic medical devices ('IVDs') consists of Directive\n98/79/EC. It has demonstrated its merits but has also come under\ncriticism in recent years. In an internal market with 32\nparticipating countries and subject to constant scientific and\ntechnological progress, substantial divergences in the\ninterpretation and application of the rules have emerged, thus\nundermining the main objectives of the Directive, i.e. the safety\nand performance of IVDs and their free movement.
\nTriggered by the PIP breast\nimplants scandal, the European Parliament adopted on 14 June 2012\na Resolution on defective silicone gel breast\nimplants made by the French\ncompany PIP and called for an adequate legal framework to guarantee\nthe safety of medical technology.
\nIMPACT ASSESSMENT: a separate\nimpact assessment has been carried out by the\nCommission.
\nLEGAL BASIS: Article 114 and Article 168(4)(c) of the\nTreaty on the Functioning of the European Union.
\nCONTENT: this revision of\nthe current regulatory framework aims to overcome the flaws and\ngaps and to further strengthen patient safety. It aims to put in\nplace a robust, transparent and sustainable regulatory framework\nfor in vitro diagnostic medical devices that is 'fit for purpose'.\nThe framework is supportive of innovation and the competitiveness\nof the in vitro diagnostic medical device industry and should allow\nrapid and cost-efficient market access for innovative IVDs to the\nbenefit of patients and healthcare professionals.
\nIt should be noted that this proposal is adopted\nalongside a proposal\nfor a Regulation on medical devices that are currently covered\nby the AIMDD and the MDD. While the specific features of IVDs and\nof the IVD sector require the adoption of a specific legislation\ndistinct from the legislation on other medical devices, the\nhorizontal aspects common to both sectors have been\naligned.
\nThe main elements of the proposal are as follows:
\nScope and definitions:\nto a large extent, the scope of the proposed Regulation matches the\nscope of Directive 98/79/EC, i.e. it covers in vitro diagnostic\nmedical devices. The proposed changes clarify and extend the scope\nof the IVD Directive. They concern:
\n\n· \nhigh-risk devices manufactured and used within a\nsingle health institution, which are subject to most of the\nrequirements set out in the proposal;
\n\n· \ntests providing information about the\npredisposition to a medical condition or a disease (e.g. genetic\ntests) and tests providing information to predict treatment\nresponse or reactions (e.g. companion diagnostics), which are\nconsidered as in vitro diagnostic medical devices;
\n\n· \nmedical software, which is explicitly mentioned\nin the definition of IVDs.
\nTo support Member States and the Commission in\ndetermining the regulatory status of products, the Commission may\nset up, in accordance with its internal rules, a group of experts\nfrom various sectors (such as IVDs, medical devices, medicinal\nproducts, human tissues and cells, cosmetics and\nbiocides).
\nDefinitions: this\nsection has been significantly extended, aligning the definitions\nin the field of in vitro diagnostic medical devices with\nwell-established European and international practice.
\nMaking available of devices, obligations of economic\noperators, CE marking, free movement: this chapter covers mainly horizontal issues similar\nfor both medical devices and IVDs. It contains provisions that are\ntypical for product-related internal market legislation and sets\nout the obligations of the relevant economic operators\n(manufacturers, authorised representatives of non-EU manufacturers,\nimporters and distributors). It also provides clarification with\nregard to the adoption and the scope of common technical\nspecifications (CTS) for in vitro diagnostic medical\ndevices.
\nThe legal obligations on manufacturers are\nproportionate to the risk class of the devices they produce.\nMinimum contents of key documents\nfor the manufacturer to demonstrate compliance\nwith the legal requirements are laid down in Annexes II and\nIII.
\nThe following concepts are new in the field of\nIVDs:
\n\n· \na requirement has been introduced that within\nthe manufacturer's organisation a 'qualified person' should be\nresponsible for regulatory compliance. Similar requirements exist\nin EU legislation on medicinal products and in the national laws\ntransposing the Directive on medical devices in some Member\nStates.
\n\n· \nsince in the case of 'parallel trade' with in\nvitro diagnostic medical devices application of the principle of\nfree movement of goods varies considerably from one Member State to\nanother and, in many cases, de facto prohibits this practice, clear\nconditions are set for enterprises involved in relabelling and/or\nrepackaging IVDs.
\nIdentification and traceability of devices,\nregistration of devices and of economic operators, summary of\nsafety and performance, Eudamed: this\nchapter addresses one of the main shortcomings of the current\nsystem: its lack of transparency. It\nconsists of the following requirements:
\n\n· \neconomic operators must be able to identify who\nsupplied them and to whom they have supplied IVDs;
\n\n· \nmanufacturers must fit their devices with a\nUnique Device Identification (UDI) which allows\ntraceability;
\n\n· \nmanufacturers/authorised representatives and\nimporters must register themselves and the devices they place on\nthe EU market in a central European database;
\n\n· \nmanufacturers of high-risk devices must make\npublicly available a summary of safety and performance with \nkey elements of the supporting clinical data;
\n\n· \nfurther development of the European databank\non medical devices (Eudamed), set up\nby Commission Decision 2010/227/EU, which will contain integrated\nelectronic systems on a European UDI, on registration of devices,\nrelevant economic operators and certificates issued by notified\nbodies, on clinical performance studies, on vigilance and on market\nsurveillance. A large part of the information in Eudamed will\nbecome publicly available.
\nThe establishment of a central registration database\nwill also do away with diverging national registration requirements\nwhich have emerged over recent years and which have significantly\nincreased compliance costs for economic operators.
\nNotified bodies: the\nproposal sets out requirements for national authorities responsible\nfor notified bodies. It leaves the ultimate responsibility for\ndesignating and monitoring notified bodies, based on stricter and\ndetailed criteria laid down in Annex VI, with the individual Member\nState . Any new designation and, in regular intervals, the\nmonitoring of notified bodies are made subject to 'joint\nassessments' with experts from other Member States and the\nCommission, thus ensuring an effective control at Union\nlevel.
\nAt the same time, the\nposition of notified bodies vis-à-vis manufacturers will be\nsignificantly strengthened, including their right and duty to carry\nout unannounced factory inspections and to conduct physical or\nlaboratory tests on devices. The proposal also requires rotation of\nthe notified body's personnel involved in the assessment of medical\ndevices at appropriate intervals.
\nClassification and conformity\nassessment: the proposal introduces a\nnew risk-rule based classification system, built on GHTF\nprinciples, which replaces the current list of IVD medical devices\nin Annex II to Directive 98/79/EC.
\nIn the new classification system, IVDs will be divided\ninto four classes of risk: A (lowest\nrisk), B, C and D (highest risk). The conformity assessment\nprocedures have been adapted to match each of these four device\nclasses. The proposal tightens and streamlines the different\nconformity assessment procedures during which the notified body\naudits the manufacturer's quality management system, checks the\ntechnical documentation, examines the design dossier or approves\nthe type of a device. These are laid down in Annexes VIII to X. One\nconformity assessment procedure provided for under the IVD\nDirective (EC verification) has been deleted and the concept of\nbatch testing has been clarified.
\nThe proposal also:
\n\n· \nreinforces the powers and responsibilities of\nnotified bodies;
\n\n· \nintroduces the obligation for notified bodies to\nnotify an expert committee of new applications for conformity\nassessment of high-risk devices.
\nClinical evidence: \nthe proposal spells out the requirements for clinical evidence for\nin vitro diagnostic medical devices that are proportionate to the\nrisk class. The key obligations are set out in Chapter VI while\nmore detailed provisions are laid down in Annex XII. While most\nclinical performance studies follow an observational design and\ntherefore the results obtained are not used for patient management\nand do not impact treatment decisions, specific requirements have\nbeen introduced in Annex XIII for the conduct of interventional\nclinical performance studies and other clinical performance studies\nwhere the conduct of the study, including specimen collection,\ninvolves invasive procedures or other risks for the subjects of the\nstudies.
\nThe concept of 'sponsor' is introduced. The scope of\nthe proposal remains restricted to clinical performance studies\ncarried out for regulatory purposes, i.e. for obtaining or\nconfirming regulatory approval for market access. Non-commercial\nclinical performance studies that do not pursue a regulatory\npurpose are not covered by this Regulation. Every interventional\nclinical performance study and other clinical performance study\ninvolving risks for the subjects of the study shall be registered\nin a publicly accessible electronic system which the Commission\nwill set up.
\nVigilance and market surveillance: the proposal introduces an\nEU portal where manufacturers must report serious incidents\nand corrective actions they have taken to reduce the risk of\nrecurrence. The information will be automatically forwarded to the\nnational authorities concerned. Where the same or similar incidents\nhave occurred, or where a corrective action has to be taken, in\nmore than one Member State, a coordinating authority will take the\ndirection in coordinating the analysis of the case.
\nAs regards market surveillance, the main objectives of\nthe proposal are to reinforce the rights and obligations of the\nnational competent authorities, to ensure effective coordination of\ntheir market surveillance activities and to clarify the applicable\nprocedures.
\nGovernance: a central\nrole in achieving harmonised interpretation and practice will be\nassigned to an expert committee (the Medical Device Coordination\nGroup or MDCG) made up of members appointed by the Member States\ndue to their role and experience in the fields of medical devices\nand in vitro diagnostic medical devices and set up by Regulation on\nmedical devices. The proposal mandates the Commission to provide\ntechnical, scientific and logistic support to the MDCG.
\nIt empowers the Commission to adopt, where\nappropriate, either implementing acts to ensure uniform application\nof this Regulation, or delegated acts to complement the regulatory\nframework for in vitro diagnostic medical devices over\ntime.
\nThe future Regulation will replace and repeal\nDirective 98/79/EC.
\nBUDGETARY IMPLICATIONS: this proposal does not have\nany direct financial implications given that the cost-relevant\narrangements are already covered in the proposal\nfor a Regulation on medical devices.
\nTo recap, the operational resources necessary for the\nimplementation of the initiative are covered by the appropriations\nproposed in the context of the proposed Health\nfor Growth programme 2014-2020.
\nEstimated impact on expenditure (operational credits):\nEUR 48.376 million, of which
\n\n· \nSpecific objective 1: establishing mechanisms to\nensure harmonised implementation of the rules by all Member States\nwith credible management at EU level with access to expertise:\ntotal EUR 29.782 million;
\n\n· \nSpecific objective 2: enhancing transparency\nregarding medical devices on the EU market, including their\ntraceability (Eudamed): total EUR 18.594 million.
\nImpact on administrative\nexpenditure: EUR 20.369 million.
\nTotal appropriations for the period are EUR 68.745\nmillion.
\nDELEGATED ACTS: the proposal contains provisions\nempowering the Commission to adopt delegated acts in accordance\nwith Article 290 of the Treaty on the Functioning of the European\nUnion (TFEU).
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the report by Peter LIESE (EPP, DE) the\nproposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe committee recommends that the position of\nParliament adopted in first reading following the ordinary\nlegislative procedure should amend the Commission proposal as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices. These parts have been assessed together\nin the two reports. The amendments cover, for example, the role,\nthe structure and the necessary improvement of the notified bodies,\nthe surveillance system, the joint assessment, the scrutiny,\nidentification and traceability and the role of the Medical Device\nCoordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work.
\nNotified bodies shall have permanent \"in house\"\ncompetent personnel and expertise.
\nThe notified body shall publish a list of its staff\nresponsible for the conformity assessment and certification of\nmedical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nThe report also made improvements to the Commission\nproposal on the following point :
\nEthics committee:\n the clinical performance study should be positively assessed\nby an independent ethics committee before it starts. The\ntime limits are slightly extended to give the ethics\ncommittee and the authorities the time necessary to assess the\nproposal.
\nGenetic test: a device\nmay only be used for the purpose of a genetic test after the person\nconcerned has given free and informed consent to it. The person\nconcerned must receive appropriate information on the nature, the\nsignificance and the implications of the genetic test before the\ndevice is used.
\nGenetic counselling:\nappropriate genetic counselling shall be mandatory before\nusing a device for the purpose of predictive and prenatal testing\nand after a genetic condition has been diagnosed. Such\ncounselling shall include medical, ethical, social, psychological\nand legal aspects and shall be carried out by\nphysicians qualified in genetic counselling.
\nConsent: a device may\nonly be used for the purpose of a genetic test after the person\nconcerned has given free and informed consent to it. The consent\nhas to be given explicitly and in writing. It can be revoked at any\ntime in writing or orally.
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nScope: the amended text\nstates that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nCompanion diagnostic means a device\nspecifically intended for and\nessential to the selection of patients with a\npreviously diagnosed condition or predisposition as suitable\nor unsuitable for a specific therapy with\na medicinal product or a range of medicinal products.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the\nRegulation: Members propose that the\nRegulation should be applicable three years after its entry\ninto force, whereas the Commission had proposed five\nyears.
\nThe European Parliament adopted amendments to\nthe proposal for a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices.
\nThe issue has been referred back to the committee\nresponsible. The vote has been postponed.
\nThe main amendments adopted in plenary were as\nfollows:
\nRelationship to the proposal on a regulation for\nmedical devices: a large part of this\nproposal on IVD (such as provisions on diabetes, HIV and DNA) is\nthe same as the Commission proposal for a regulation on medical\ndevices.
\nAs for the abovementioned proposal, the amendments\ncover, for example, the role, the structure and the necessary\nimprovement of the notified bodies, the surveillance system, the\nsetting up of a Medical Device Advisory Committee, the obligation\nof manufacturers to take liability insurance with sufficient\nminimum coverage, the joint assessment, the scrutiny,\nidentification and traceability, improved access to information for\nthe general public and healthcare professionals and the role of the\nMedical Device Coordination Group (MDCG).
\nMembers proposed, in particular, to improve the\nsystem of notified bodies. The personnel of the national\nauthority responsible for auditing the work of personnel of\nnotified bodies must have proven qualifications to do\ntheir work. Notified bodies shall have permanent \"in house\"\ncompetent personnel and expertise. The notified body shall publish\na list of its staff responsible for the conformity assessment and\ncertification of medical devices.
\nThe transparency of fees charged by notified\nbodies for conformity assessment activities must be\nensured.
\nParliament also made improvements to the Commission\nproposal on the following points:
\nTesting of minors and incapacitated\nsubjects: in the case of minors the\ninformed consent of the parents or legal representative or minors\nthemselves shall be obtained in accordance with national laws;\nconsent shall represent the minors presumed will and may\nbe revoked at any time, without detriment to the minor. In the\ncase of incapacitated subjects who are unable to give informed\nlegal consent, the informed consent of the legal representative\nshall be obtained.
\nStrict rules for persons unable to give informed\nconsent such as children and incapacitated persons should be\nestablished at the same level as in Directive 2001/20/EC on\nclinical trials.
\nNo incentives or financial inducements are given\nexcept compensation for participation in the clinical performance\nstudy.
\nNon-discrimination: the\ntext should reflect the UN Convention on non-discrimination on\ndisabled people. Regarding definitions, for example, the term\n'congenital abnormality' is viewed by persons with disabilities and\ntheir representatives as discrimination, and it is proposed to\nreplace it.
\nTaking account of the needs of SMEs: in the area of in vitro diagnostic medical\ndevices many companies offering these devices are SMEs, and\namendments are proposed in the report to alleviate the burden. For\nexample it must be possible to provide some information\nelectronically and it is also specified that the information\naccompanied the product shall be provided in an official union\nlanguage and not in any other language.
\nAdvisory Committee:\nParliament called for a multidisciplinary Medical Device Advisory\nCommittee (MDAC) to be set up which should be composed of experts\nand representatives of the relevant stakeholders should be set up\nto provide scientific advice to the Commission, the Medical Device\nCoordination Group (MDCG) and Member States on issues of medical\ntechnology, regulatory status of devices and other aspects of\nimplementation of this Regulation as necessary.
\nScope: the amended text\nstated that certain devices may only be supplied on a medical\nprescription, particularly Class D devices (high risk) and\nClass C devices in the following categories: (a) devices for\ngenetic testing; (b) companion diagnostics.
\nDirect to consumer advertising of devices classed as prescription only by this\nRegulation shall be illegal.
\nDelegated acts: basic\naspects elements of the Regulation such as general safety and\nperformance requirements, elements to be addressed in technical\ndocumentation, the minimum content of the Union declaration of\nconformity, amending or supplementing the conformity assessment\nprocedures, should only be amended through the ordinary legislative\nprocedure.
\nApplication of the Regulation: Members proposed that the Regulation should be\napplicable three years after its entry into force, whereas\nthe Commission had proposed five years.
\nThe European Parliament adopted by 492 to 21, with 117\nabstentions, a legislative resolution on the proposal for a\nregulation of the European Parliament and of the Council on in\nvitro diagnostic medical devices.
\nThe report was sent back to the committee at the 22\nOctober 2013 plenary sitting.
\nParliament adopted as its position at first reading\nthe text adopted on 22 October 2013 (please refer to the summary of that\ndate).
\nThe Council took note of a presidency progress report on two draft regulations on medical devices and on in vitro diagnostic medical devices.
Ministers provided guidance for future work on these files as regards the three following elements:
(1) The designation of conformity assessment bodies as notified bodies and the monitoring of these bodies: most Member States supported the idea of further clarifying the procedures for designating notified bodies and strengthening cooperation between Member States to ensure that notified bodies meet similar standards throughout the EU. But they also warned against increasing the administrative burden unnecessarily.
(2) The reporting of incidents, market surveillance and corrective measures: all Member States supported strengthened requirements on post-market surveillance and responsibility for follow-up by manufacturers, e.g. by collecting and analysing data on the performance of medical devices, in particular on adverse reactions in which they are involved.
However, as regards the balance between controls before and after placing devices on the market there were diverging views.
(3) The role and tasks of the medical device coordination group (MDCG): all delegations support the establishment of the MDCG. Most delegations support the idea to unify co-operation between Member States regarding medical devices and in vitro diagnostic medical devices by appointing one representative per Member State in the Medical Device Coordination Group (MDCG) rather than separate representatives for medical devices and in vitro diagnostic medical devices. There is broad agreement that the establishment of a network of reference laboratories is important for the proper evaluation of in vitro diagnostic medical devices.
As regards the evaluation of medical devices, however, many delegations have expressed an interest in either complementing the reference laboratories with device panels or replacing them entirely with device panels in order to provide relevant expertise input for regulatory measures.
Overall, many Member States stressed the need to develop a consistent legislative package that guarantees patient safety and facilitates innovation in order to improve treatments, decrease costs for patients and taxpayers, and preserve the competitiveness of the EU industry.
The Council instructed its preparatory bodies to continue examining the two files with a view to agreeing a Council position in the autumn. \n\t\t \t\t\t\t\t\t
The Council took note of a presidency progress\nreport on two draft regulations on medical devices and in\nvitro diagnostic medical devices.
\nThe report noted that considerable progress has been\nachieved on these files under the Italian presidency. However,\nfurther discussions are needed for the Council to agree its\nposition.
\nOutstanding issues include:
\nThe Presidency is satisfied to have contributed to the\nprogress of the work and intends to compile complete texts for\nboth proposals by the end of its tenancy.
\nThe Council adopted its position at first reading with\na view to the adoption of a Regulation of the European Parliament\nand of the Council on in-vitro diagnostic medical devices\nwhich replaces Council Directive 98/79/EC and Commission Decision\n2010/227/EU.
\nThe proposed Regulation aims to put in place a robust,\ntransparent and sustainable regulatory framework for in\nvitro diagnostic medical devices for human use in the\nEuropean Union (e.g. HIV blood tests, pregnancy tests, blood sugar\nmonitoring systems for diabetics). It shall apply to performance\nstudies concerning such in vitro diagnostic medical devices and\naccessories conducted in the Union.
\nIts objective is to enhance patient safety by:\n(i) introducing more stringent procedures for conformity assessment\nand for post-marketing surveillance, and (ii) requiring\nmanufacturers to produce clinical safety data, performance and\nunknown side-effects.
\nNotified bodies: the\nCouncil position strengthens the rules regarding notified bodies in\norder to ascertain that notified bodies are designated and operate\nunder harmonised conditions throughout the Union. These rules\nprovide a stronger mandate to independent notified bodies in their\nassessment of in vitro diagnostic medical devices before\nthey can be placed on the market.
\nAvailability of clinical data: the requirements on collection of data in clinical\ninvestigations on medical devices and performance studies on in\nvitro diagnostic medical devices have been considerably\nstrengthened and aligned to those applicable for clinical trials on\nmedicinal products for human use, particularly as regards\nprovisions on informed consent and protection of vulnerable\nsubjects.
\nThe Councils position sets out the verification\nby a designated reference laboratory of the performance claimed by\nmanufacturers and a consultation with an expert panel as regards\nthe evaluation for certain high-risk devices.
\nInformation and counselling for genetic\ntesting: Member States shall\nensure that where a genetic test is used on individuals in the\ncontext of healthcare, the subject to the testing must be provided\nwith relevant information on the nature, significance and\nimplications of the test, as appropriate. In particular, there\nshould be appropriate access to counselling where genetic testing\nprovides information on diseases that are considered to be\nuntreatable.
\nLiability:\nmanufacturers' responsibilities are clearly set out for the\nfollow-up of the quality, performance and safety of devices\nplaced on the market. The Council requested that manufacturers\nshould put in place measures to provide sufficient financial\ncoverage in respect of their potential liability under\nDirective 85/374/EEC concerning liability for defective\nproducts.
\nThe authorised representative would be jointly\nand severally liable with the importer and manufacturer in case of\ndamages suffered due to defective devices.
\nIdentification and traceability related\nobligations: the Councils\nposition sets out detailed rules for the implementation of the\nUnique Device Identification (UDI) system. The main features of the\nposition are the requirement for manufacturers to have the UDI code\nassigned to their devices by the date of application and the\nrequirement for the UDI carrier to be placed on the device and all\nhigher levels of packaging gradually depending on the risk class of\nthe device.
\nClassification: the\nclassification system for medical devices, and, even further, the\nclassification system for in vitro diagnostic medical\ndevices have been adapted to correspond to the rapid increase in\nscientific, medical and technical knowledge and to the resulting\ndevelopment of more and more advanced device.
\nEuropean Medical Devices Database\n(EUDAMED): the proposed Regulation\nensures greater transparency of information on devices\nplaced on the market by setting up a central database to provide\npatients, healthcare professionals and the public with\ncomprehensive information on products available in the\nEU.
\nThe Committee on the Environment, Public Health and\nFood Safety adopted the recommendation for second reading contained\nin the report by Peter LIESE (EPP, DE) on the Council position at\nfirst reading with a view to the adoption of a regulation of the\nEuropean Parliament and of the Council on in vitro diagnostic\nmedical devices and repealing Directive 98/79/EC and Commission\nDecision 2010/227/EU.
\nThe committee recommended the European Parliament to\napprove the Council position at first reading without\namendments. It also took note of two Commission statements\nannexed to the draft legislative resolution.
\nThe Commission:
\nCouncils first reading position is in conformity\nwith the agreement reached during the interinstitutional\nnegotiations. The report is accompanied by a short justification\nwhich focuses on the following elements of the approved\ntext:
\nThe European Parliament adopted a legislative\nresolution on the Council position at first reading with a view to\nthe adoption of a regulation of the European Parliament and of the\nCouncil on in vitro diagnostic medical devices and repealing\nDirective 98/79/EC and Commission Decision 2010/227/EU.
\nA proposal to reject the Council proposal, submitted\nby the EFDD group, was rejected in plenary by 59 votes to 635, with\n9 abstentions.
\nIn line with the recommendation for second reading by\nits Committee on the Environment, Public Health and Food Safety,\nParliament approved the Council position at first reading\nwithout amendments.
\nThe proposed Regulation seeks to harmonise the rules\nfor the placing on the market and putting into service of in vitro\ndiagnostic medical devices (e.g. HIV blood tests, pregnancy tests,\nblood sugar monitoring systems for diabetics) and their accessories\non the Union market which may then benefit from the principle of\nfree movement of goods.
\nParliament took note of two Commission\nstatements annexed to the legislative resolution. With these\nstatements, the Commission:
\n