51 Amendments of Margrete AUKEN related to 2012/0267(COD)
Amendment 77 #
Proposal for a regulation
Recital 8
Recital 8
(8) It should be the responsibility of the Member StatesCommission 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.
Amendment 86 #
Proposal for a regulation
Recital 27
Recital 27
(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.
Amendment 94 #
Proposal for a regulation
Recital 35
Recital 35
(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.
Amendment 95 #
Proposal for a regulation
Recital 35
Recital 35
(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.
Amendment 97 #
Proposal for a regulation
Recital 38
Recital 38
(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 DC, 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.
Amendment 99 #
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (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.
Amendment 108 #
Proposal for a regulation
Recital 55
Recital 55
(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.
Amendment 109 #
Proposal for a regulation
Recital 65
Recital 65
(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 1812 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.
Amendment 110 #
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
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.
Amendment 115 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘device for self-testing’ 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;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 12 a (new)
(12a) ‘ device for genetic testing’ 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.
Amendment 134 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
Article 2 – paragraph 1 – subparagraph 7 – point 58 a (new)
(58a) ‘ethics committee’ 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.
Amendment 136 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
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 mayare 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 mayshall make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 144 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 150 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 1
Article 8 – paragraph 2 – subparagraph 1
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.
Amendment 155 #
Proposal for a regulation
Article 8 – paragraph 9
Article 8 – paragraph 9
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.
Amendment 161 #
Proposal for a regulation
Article 8 a (new)
Article 8 a (new)
Article 8 a To ensure that patients harmed will be compensated for any damages and to avert manufacturer’s insolvency, manufacturers shall be obliged to take out liability insurance with sufficient minimum coverage.
Amendment 174 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
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. 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.
Amendment 183 #
Proposal for a regulation
Article 16 a (new)
Article 16 a (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.
Amendment 189 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) the compatibility with other traceability systems used by the stakeholders involved with medical devices.
Amendment 190 #
Proposal for a regulation
Article 23 – paragraph 1
Article 23 – paragraph 1
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.
Amendment 191 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summaryextensive report of safety and performance. It shall be written in a way that is clear to the intended user. The draft of this summaryextensive 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.
Amendment 193 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
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.
Amendment 198 #
Proposal for a regulation
Article 26 – paragraph 7
Article 26 – paragraph 7
7. Member States shall provide the Commission and, the other Member States withand 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.
Amendment 200 #
Proposal for a regulation
Article 26 – paragraph 8 – subparagraph 2
Article 26 – paragraph 8 – subparagraph 2
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.
Amendment 210 #
Proposal for a regulation
Article 30 – paragraph 3
Article 30 – paragraph 3
3. Within 14 days of the submission referred to in paragraph 2, the Commission shall designate a joint assessment team, made up of at least twohree experts chosen from a list of experts who are qualified in the assessment of conformity assessment bodies. The list shall be drawn up by the Commission in cooperation with the MDCG. At least one of these experts shall be a representative of the Commission who shall lead the joint assessment team.
Amendment 211 #
Proposal for a regulation
Article 30 – paragraph 4 – subparagraph 1
Article 30 – paragraph 4 – subparagraph 1
Within 90 days after designation of the joint assessment team, the national authority responsible for notified bodies and the joint assessment team shall review the documentation submitted with the application in accordance with Article 29 and conduct an on-site assessment of the applicant conformity assessment body and, where relevant, of any subsidiary or sub- contractor, located inside or outside the Union, to be involved in the conformity assessment process. Such on-site assessment shall not cover requirements for which the applicant conformity assessment body has received a certificate delivered by the national accreditation body as referred to in Article 29(2), unless the Commission representativea member of the joint assessment team mentioned in Article 30(3) requests the on-site assessment.
Amendment 213 #
Proposal for a regulation
Article 30 – paragraph 6
Article 30 – paragraph 6
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 which t. The relevant national authority shall duly take into considerfully respect this binding recommendation for its decision on the designation of the notified body.
Amendment 217 #
Proposal for a regulation
Article 31 – paragraph 5
Article 31 – paragraph 5
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 followagree with the recommendation of the MDCG, it shallmay provide a duly substantiated justificationargumentation for its opinion that will be publicly available.
Amendment 219 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
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 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.
Amendment 223 #
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
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.
Amendment 238 #
Proposal for a regulation
Chapter 5 – title
Chapter 5 – title
Classification, marketing authorisation and conformity assessment
Amendment 250 #
Proposal for a regulation
Article 39 a (new)
Article 39 a (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.
Amendment 251 #
Proposal for a regulation
Article 39 b (new)
Article 39 b (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.
Amendment 252 #
Proposal for a regulation
Article 39 c (new)
Article 39 c (new)
Amendment 253 #
Proposal for a regulation
Article 39 d (new)
Article 39 d (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;
Amendment 254 #
Proposal for a regulation
Article 39 e (new)
Article 39 e (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.
Amendment 255 #
Proposal for a regulation
Article 39 f (new)
Article 39 f (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.
Amendment 256 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 1
Article 40 – paragraph 2 – subparagraph 1
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 Xentralised marketing authorisation procedure.
Amendment 259 #
Proposal for a regulation
Article 40 – paragraph 2 – subparagraph 2
Article 40 – paragraph 2 – subparagraph 2
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, when available, or with other solutions chosen by the manufacturer to ensure a level of safeas 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 sperformance that is at least equivalent, as specified in Section 5.4 of Annex VIII ancificity using reference materials and diagnostic sensitivity and specificity using specimens from early and established in Sfection 3.5 of Annex IX.
Amendment 282 #
Proposal for a regulation
Article 49 – paragraph 2 – subparagraph 1 a (new)
Article 49 – paragraph 2 – subparagraph 1 a (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.
Amendment 288 #
Proposal for a regulation
Article 50 – paragraph 3 – introductory part
Article 50 – paragraph 3 – introductory part
3. The information shall be fully 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:.
Amendment 289 #
Proposal for a regulation
Article 50 – paragraph 3 – point a
Article 50 – paragraph 3 – point a
Amendment 290 #
Proposal for a regulation
Article 50 – paragraph 3 – point b
Article 50 – paragraph 3 – point b
Amendment 292 #
Proposal for a regulation
Article 50 – paragraph 3 – point c
Article 50 – paragraph 3 – point c
Amendment 293 #
Proposal for a regulation
Article 51 – paragraph 1 – introductory part
Article 51 – paragraph 1 – introductory part
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:
Amendment 296 #
Proposal for a regulation
Article 51 – paragraph 2
Article 51 – paragraph 2
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, tThe information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission., to the Commission, and the Commission shall also ensure that healthcare professionals and patients have access to the electronic system
Amendment 309 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1
Article 59 – paragraph 3 – subparagraph 1
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.
Amendment 347 #
Proposal for a regulation
Annex 1 – part II – point 16 a (new)
Annex 1 – part II – point 16 a (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.
Amendment 357 #
Proposal for a regulation
Annex 2 – point 7 (new)
Annex 2 – point 7 (new)
7. Public access to technical documentation The technical documentation and clinical evidence submitted by manufacturers to notified bodies must be made publicly available.
Amendment 359 #
Proposal for a regulation
Annex 5 – section 1 – paragraph 1 – point 18 a (new)
Annex 5 – section 1 – paragraph 1 – point 18 a (new)
18 a. Full technical documentation and the clinical performance report.