Activities of Nora BERRA related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Amendments (77)
Amendment 90 #
Proposal for a regulation
Recital 34
Recital 34
(34) The traceability of 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 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.
Amendment 96 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, as well as products using external physical agents, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 122 #
Proposal for a regulation
Article 16 – paragraph 1 – subparagraph 1 b (new)
Article 16 – paragraph 1 – subparagraph 1 b (new)
The first subparagraph of paragraph 1 shall not apply to dental filling material, staples or sutures.
Amendment 138 #
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
Amendment 153 #
Proposal for a regulation
Recital 8
Recital 8
(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, when necessary, as for example when for a same product the decisions taken at national level vary between Member States, on a case-by- case basis, whether or not a product falls within the definition of a medical device or of an accessory to a medical device. Since in some cases it is difficult to distinguish between medical devices and cosmetic products, the possibility to take an EU- wide decision regarding the regulatory status of a product should also be introduced in Regulation No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products.
Amendment 159 #
Proposal for a regulation
Recital 13
Recital 13
(13) There is scientific uncertainty about the risks and benefits of nanomaterials used for medical devices. In order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers, it is necessary to introduce a uniform definition for nanomaterials based on Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial, with the necessary flexibility to adapt this definition to scientific and technical progress and subsequent regulatory development at Union and international level. In the design and manufacture of medical devices, the manufacturers should take special care when using nanoparticles that can bewhich are intended to be intentionally released toin the human body and those devices should be subject to the most severe conformity assessment procedure.
Amendment 165 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25a) To ensure that the risk of damage as well as the risk of the manufacturer's insolvency are not shifted to patients harmed by medical devices and that the payers are liable for the cost of treatment, manufacturers shall be obliged to take liability insurance with appropriate minimum coverage.
Amendment 172 #
Proposal for a regulation
Recital 31
Recital 31
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, call for regulation of the reprocessing of single- use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device. For more clarity, only 'intended single-use device' should be reprocessed and not 'single-use device'. Therefore, with regard to reprocessing, 'multiple-use device', 'intended single-use device' and 'single- use device' should be defined in this Regulation and those terms should be distinguished one from another.
Amendment 178 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – paragraph 3 – subparagraph 1
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.
Amendment 188 #
Proposal for a regulation
Recital 42
Recital 42
(42) For innovative high risk medical devices, competent authorities should be informed at an early stage about devices which are subject to conformity assessment and be given the right, oin scientifically valid grounds, to scrutinise the preliminary assessment conducted by notified bodies,absence of common technical specification or guideline for the conduct of clinical evaluation, to assess clinical data and proceed with a scientific assessment in particular regarding novel devices, devices 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 medical device before submitting the application to the notified body.
Amendment 190 #
Proposal for a regulation
Recital 42 a (new)
Recital 42 a (new)
(42a) High-risk devices manufacturer concerned by the scientific assessment should be provided with an advice for an appropriate assessment of the conformity of their devices, in particular with regard to the clinical data required for the clinical evaluation. This scientific advice could be provided by the Scientific Advisory Board or by an EU reference laboratory and published on a public database.
Amendment 204 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Devices that are composed of substances or combination of substances primarily intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by orand dispersed in the human body in order to achieve their intended purpose are in class III.
Amendment 207 #
Proposal for a regulation
Recital 54 a (new)
Recital 54 a (new)
(54a) Manufacturers should report periodically on medical devices classified as class III as regards the data relevant to the risk benefit ratio and the exposition of the population in order to evaluate whether any action concerning the medical device concerned is necessary.
Amendment 209 #
Proposal for a regulation
Recital 56
Recital 56
(56) Rules on market surveillance should be included in this Regulation to reinforce the rights and obligations of the national competent authorities, to ensure effective coordination of their market surveillance activities and to clarify the applicable procedures. The Commission should clearly define the way these inspections should be conducted in order to ensure a full and harmonized implementation within the Union.
Amendment 211 #
Proposal for a regulation
Recital 59
Recital 59
(59) 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 to fulfil the tasks conferred on it by this Regulation and by Regulation (EU) […/….../...] on in vitro diagnostic 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. That experts committee should be supported by a Scientific Advisory Board composed of expert panels for specific medical disciplines in order to proceed with the assessment of high risk device and provide guidelines and common technical specifications for clinical evaluation.
Amendment 212 #
Proposal for a regulation
Annex 15 – point 4
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;
Amendment 237 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 5 – paragraph 2
The implantable or other invasive products, and products using external physical agents, intended to be used for human beings, which are listed in Annex XV shall be considered medical devices, regardless of whether or not they are intended by the manufacturer to be used for a medical purpose.
Amendment 244 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 4 – introductory part
(4) ‘'active device’' means any device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or by gravity and which acts by changing the density of or converting this energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be considered to be active devices.
Amendment 249 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 – introductory part
Article 2 – paragraph 1 – subparagraph 1 – point 8 – introductory part
(8) ‘'single-use device’' means a device that is intended to be used on an individual patient during a single procedure and which has been tested and demonstrated to be impossible to reuse.
Amendment 250 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 8 a (new)
(8a) "intended for single-use device" means a device that is intended to be used on an individual patient during a single procedure for which impossibility of reuse has not been demonstrated;
Amendment 251 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 8 b (new)
Article 2 – paragraph 1 – subparagraph 1 – point 8 b (new)
(8b) 'multiple-use device' means a device which is reusable and must be provided with information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be re- sterilized, and any restriction on the number of reuses;
Amendment 272 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, on its own initiative or shall at the request of a Member State or on its own initiative, by means of implementing acts, determine whether or not a specific product, or category or group of products, falls within the definitions of ‘'medical device’' or ‘'accessory to a medical device’. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 289 #
Proposal for a regulation
Article 7 – paragraph 1
Article 7 – paragraph 1
1. Where no harmonised standards exist or where relevant harmonised standards are not sufficientthere is a need to address public health concerns, tThe 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 evaluation and post- market clinical follow-up set out in Annex XIII. The CTS shall be adopted by means of implementing acts in accordance with the examination procedure referred to in Article 88(3).
Amendment 292 #
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Article 7 – paragraph 1 a (new)
Amendment 295 #
Proposal for a regulation
Article 7 – paragraph 1 b (new)
Article 7 – paragraph 1 b (new)
1b. Commission shall adopt CTS referred to in paragraph 1 after consulting the MDCG, which shall also include a representative of the European standardisation organisations.
Amendment 307 #
Proposal for a regulation
Article 8 – paragraph 7
Article 8 – paragraph 7
7. Manufacturers shall ensure that the device is accompanied by the instructions and safety information to be supplied in accordance with Section 19 of Annex I in an official Union language which can be easily understood by the intended user or patient. The language(s) of the information to be supplied by the manufacturer may be, as determined by the law of the Member -State where the device is made available to the user or patientconcerned.
Amendment 314 #
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 a competent authority considers or has reason to believe that a device has caused damages, it shall ensure that the potentially harmed user, the user's successor in title, the user's health insurance company or other third parties affected by the damage caused to the user may request the information referred to in the first subparagraph from the manufacturer.
Amendment 316 #
Proposal for a regulation
Article 8 – paragraph 10 a (new)
Article 8 – paragraph 10 a (new)
10a. Manufacturers shall have an appropriate liability insurance covering any damages that may be caused by their medical devices to patients or users. That insurance shall at least cover damage in the following cases: (a) in the event of the death of or injury to patient or user; or, (b) in the event of the death of or injury to multiple patients or users due to the use of the same medical device.
Amendment 323 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point b
Article 11 – paragraph 2 – subparagraph 1 – point b
(b) that the manufacturer is identified and that an authorised representative in accordance with Article 9 has been designated by the manufacturer;
Amendment 324 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
Article 11 – paragraph 2 – subparagraph 1 – point f a (new)
(fa) that the manufacturer has taken out appropriate liability insurance coverage pursuant to Article 8 (10) unless the importer himself can ensure sufficient coverage corresponding to the same requirements.
Amendment 327 #
Proposal for a regulation
Article 11 – paragraph 7
Article 11 – paragraph 7
7. Importers 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 inform the manufacturer, and where applicable his authorised representative and, if appropriate, takeensure that the necessary corrective action to bring that device into conformity, withdraw or recall it, is taken and, implement that action. 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 45 for the device in question, giving details, in particular, of the non- compliance and of any corrective action takenhey have implemented.
Amendment 381 #
Proposal for a regulation
Article 15 – title
Article 15 – title
Amendment 383 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses an intended single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation.
Amendment 389 #
Proposal for a regulation
Article 15 – paragraph 2
Article 15 – paragraph 2
2. Only intended single-use devices that have been placed on the Union market in accordance with this Regulation, or prior to [date of application of this Regulation] in accordance with Directive 90/385/EEC or Directive 93/42/EEC may be reprocessed.
Amendment 397 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. The Commission, by means of implementingdelegated acts, shall establish and regularly update a list of categories or groups of intended single-use devices for critical use which may be reprocessed in accordance with paragraph 3. Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 88(3)9.
Amendment 399 #
Proposal for a regulation
Article 15 – paragraph 5 – subparagraph 2
Article 15 – paragraph 5 – subparagraph 2
The name and address of the manufacturer of the original intended single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
Amendment 403 #
Proposal for a regulation
Article 15 – paragraph 6 – subparagraph 1 – point a
Article 15 – paragraph 6 – subparagraph 1 – point a
(a) the reprocessing of intended single-use devices and the transfer of intended single- use devices to another Member State or to a third country with a view to their reprocessing;
Amendment 404 #
Proposal for a regulation
Article 15 – paragraph 6 – subparagraph 1 – point b
Article 15 – paragraph 6 – subparagraph 1 – point b
(b) the making available of reprocessed intended single-use devices.
Amendment 408 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall provide together with the device an implant card which shall be made available to the particular patient who has been implanted with the device. This paragraph shall not apply to clips, sutures and dental fillings.
Amendment 409 #
Proposal for a regulation
Article 16 – paragraph 1
Article 16 – paragraph 1
1. The manufacturer of an implantable device shall providmake available in advance toge ther with the device an implant card which shall be made available healthcare professional or where relevant, to the particular patient who has beenis going to be implanted with the device, the information to be included in an implant passport or in an implant card.
Amendment 432 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Any natural or legal person who makes available on the market an article intended specifically to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or re-establish the function of the device without significantly changing its performance or safety characteristics, shall ensure that the article does not adversely affect the safety and performance of the device. Substantiating evidence shall be kept available to the competent authorities of the Member States.
Amendment 456 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. In the case of devices classified as class III and implantable devices, other than custom-made or investigational devices, the manufacturer shall draw up a summary of safety and clinical performance. It shall be written in a way that is clear to the intended user and shall update it with the conclusions of the post market clinical follow-up evaluation report referred to in point 3 of Part B of Annex XIII. It shall be written in a way that is clear to the intended use and in the language of the country where the medical device is made available on the market. 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 42 and shall be validated by that body.
Amendment 535 #
Proposal for a regulation
Article 41 – paragraph 3 – subparagraph 1
Article 41 – paragraph 3 – subparagraph 1
The Commission may, at the request of a Member State or on its own initiative, by means of implementing acts, decide on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices, with a view to determining their classification. Such decision should in particular be taken in order to resolve diverging decisions between Member States.
Amendment 547 #
Proposal for a regulation
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Article 42 – paragraph 10 – subparagraph 1 – indent 2
Amendment 565 #
Proposal for a regulation
Article 44 – title
Article 44 – title
Amendment 568 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments forFor implantable devices, classified as class III, 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 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicatethe notified body, before delivering the certificate of conformity, shall request a scientific assessment provided by MDCG on the clinical evaluation and the eposti-mated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCGrket clinical follow-up.
Amendment 571 #
Proposal for a regulation
Article 44 – paragraph 1 – subparagraph 1 (new)
Article 44 – paragraph 1 – subparagraph 1 (new)
Notwithstanding subparagraph 1 of Article 44(1), this requirement shall not apply to devices for which specifications referred to in Articles 6 and 7 have been published for the clinical evaluation and the post-market clinical follow-up and devices for which the application for certification only aims at supplementing or renewing existing certificates.
Amendment 575 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Article 44 – paragraph 2 – subparagraph 1
Amendment 577 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 2
Article 44 – paragraph 2 – subparagraph 2
Amendment 582 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. The MDCG may submit comments on the summary of the preliminary conformityscientific assessment is based on an assessment atof the latest 60 days after submission of this summary. Within that period and at the latest 30 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of commentsdossier by the Scientific Advisory Board referred to in Article 80a. If for a device concerned, the manufacturer requested a scientific advice following the procedure referred to in Article 82a, the outcome of that procedure shall be submitted together with the notification or as soon as that procedure is completed. The scientific advice shall be duly taken into account by the MDCG and the Commission in the course of the implementation of this Article.
Amendment 585 #
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comments received, and its final decision regarding the conformity assessment in question. The CommissIn case of a favourable scientific assessment, the notified body may proceed with the certification. However, if the favourable scientific assessment is dependant on the application of specific measures (e.g. adaptation of the post- market clinical follow-up plan, certification with a time limit), the notified body shall issue the certificate of conformity only on the condition sthall immediately transmit this information to the MDCGt those measures are implemented.
Amendment 586 #
Proposal for a regulation
Article 44 – paragraph 4 – subparagraph 1 (new)
Article 44 – paragraph 4 – subparagraph 1 (new)
In case of unfavourable scientific assessment, the notified body shall not deliver the certificate of conformity. Nevertheless, the notified body may submit new information in response to the explanation included in the MDCG scientific assessment. At the request of the manufacturer, the Commission shall organise a hearing allowing discussion on the scientific grounds for the unfavourable scientific assessment and any action that the manufacturer may take or data that may be submitted to address the MDCG concerns
Amendment 587 #
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 1
Article 44 – paragraph 5 – subparagraph 1
Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific devices, categories or groups of devices, other than devices of class III,referred to in paragraph 1 to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).
Amendment 590 #
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 2 – point a
Article 44 – paragraph 5 – subparagraph 2 – point a
(a) the novelty of the device or of the technology on which it is based and thechnological novelty or new therapeutic use, which can have significant clinical or public health impact thereof;
Amendment 597 #
Proposal for a regulation
Article 44 a (new)
Article 44 a (new)
Article 44 a Notification before placing on the market 1. Notified bodies shall notify the Commission of applications for conformity assessments for devices classified as class III, except applications to supplement or renew existing certificates. Those notifications shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notifications 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. 2. The Commission shall be empowered to adopt delegated acts in accordance with Article 89 to extend the scope of devices which must be notified before placing on the market as referred to in paragraph 1.
Amendment 633 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1 – point a
Article 61 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 639 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 2
Article 61 – paragraph 3 – subparagraph 2
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. The Member States shall also provide healthcare professionals, users and patients with another forms for reporting of suspected incidents to national competent authorities.
Amendment 643 #
Proposal for a regulation
Article 62 – paragraph 1 – point d a (new)
Article 62 – paragraph 1 – point d a (new)
(d a) the periodic safety update reports drawn by manufacturers, as referred to in Article 63a;
Amendment 649 #
Proposal for a regulation
Article 62 – paragraph 5 a (new)
Article 62 – paragraph 5 a (new)
5 a. The reports and information referred to in Article 62(5), shall also be automatically transmitted as regards the device in question via the electronic system to the notified body that issued the certificate in accordance with Article 45.
Amendment 651 #
Proposal for a regulation
Article 63 a (new)
Article 63 a (new)
Article 63 a Periodic safety update reports 1. Manufacturers of medical devices classified as class III shall report to the electronic system referred to in Article 62: (a) summaries of data relevant to the benefits and risks of the medical devices, including results of all studies with a consideration of their potential impact on the certification; (b) a scientific evaluation of the risk- benefit ratio of the medical device; (c) all data relating to the volume of sales of the medical devices including an estimate of the population exposed to the medical device. 2. The frequency with which the manufacturers shall make the report referred to in the paragraph 1 shall be specified in the MDCG scientific assessment referred to in Article 44. Manufacturers shall submit periodic safety update reports to the competent authorities immediately upon request or at least once a year during the first 2 years following initial placing on the market of that medical device. 3. The MDCG shall assess periodic safety update reports to determine whether there are new risks or whether risks have changed, or whether there are changes to the risk-benefit ratio of the medical device. 4. Following the assessment of periodic safety update reports, the MDCG shall consider whether any action regarding the medical device concerned is necessary. The MDCG shall inform the notified body in case of unfavourable scientific assessment. In this case, the notified body shall maintain, vary, suspend or revoke the authorisation as appropriate.
Amendment 653 #
Proposal for a regulation
Article 63 – paragraph 1 – subparagraph 2
Article 63 – paragraph 1 – subparagraph 2
If in the case of reports received in accordance with Article 61(3) the competent authority ascertains that the reports relate to a seriousn incident it shall notify without delay those reports to the electronic system referred to in Article 62, unless the same incident has already been reported by the manufacturer.
Amendment 670 #
Proposal for a regulation
Article 67 – paragraph 1
Article 67 – paragraph 1
1. The competent authorities shall perform appropriate checks on the characteristics and performance of devices including, where appropriate, review of documentation and physical or laboratory checks on the basis of adequate samples. They shall take account of established principles regarding risk assessment and risk management, vigilance data and complaints. The competent authorities may require economic operators to make available the documentation and information necessary for the purpose of carrying out their activities and, where necessary and justified, enter the premises of economic operators and take the necessary samples of devices for analysis by an official laboratory. They may destroy or otherwise render inoperable devices presenting a serious risk where they deem it necessary.
Amendment 672 #
Proposal for a regulation
Article 67 – paragraph 1 a (new)
Article 67 – paragraph 1 a (new)
1 a. The competent authorities shall designate inspectors who shall be empowered to carry out the checks referred to in paragraph 1. Those checks may be assisted by experts appointed by the competent authorities. The checks shall be carried out by the inspectors of the Member State in which the economic operator is located.
Amendment 676 #
Proposal for a regulation
Article 67 – paragraph 5 a (new)
Article 67 – paragraph 5 a (new)
5 a. Without prejudice to any international agreements concluded between the Union and third countries, checks as referred in paragraph 1 can also take place in the premises of an economic operator located in a third country, if the device is intended to be made available on the Union market.
Amendment 677 #
Proposal for a regulation
Article 67 – paragraph 5 b (new)
Article 67 – paragraph 5 b (new)
5 b. After every check, as referred in paragraph 1, the concerned competent authority shall report to the inspected economic operator on the level of compliance with this Regulation. Before adopting the report, the competent authority shall give the inspected economic operator the possibility to submit comments.
Amendment 678 #
Proposal for a regulation
Article 67 – paragraph 5 c (new)
Article 67 – paragraph 5 c (new)
5 c. The Commission shall establish detailed guidelines on the principles for carrying out the checks referred to in this Article including in particular on the qualifications of inspectors, and on inspection arrangements and access to data and information held by economic operators.
Amendment 708 #
Proposal for a regulation
Article 78 – paragraph 7 a (new)
Article 78 – paragraph 7 a (new)
7 a. The MDCG shall establish a stakeholder dialogue group made up of stakeholders representatives organised at Union level. Such group shall act in parallel and work with the Medical Device Coordination Group (MDCG), advising the Commission and Member States on various aspects of medical technology and implementation of the Regulation.
Amendment 721 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
(b) to contribute to the scrutinyprovide a scientific assessment ofn certain conformity assessmenttypes of medical devices pursuant to Article 44;
Amendment 738 #
Proposal for a regulation
Article 80 a (new)
Article 80 a (new)
Article 80 a Scientific Advisory Board 1. The Commission shall set up and provide the logistic support for a Scientific Advisory Board made up of not more than 15 scientific and/or clinical experts in the field of medical devices, appointed in their personal capacity by the MDCG. 2. When appointing these experts, the Commission shall ensure a broad, appropriate and balanced coverage of the medical disciplines relevant for medical devices, the publication of any interests which might affect the conduct of their work and the signature of a confidentiality clause. The Scientific Advisory Board may establish under its responsibility expert panels for specific medical disciplines. The Commission or the MDCG may request the Scientific Advisory Board to provide scientific advice on any issue related to the implementation of this Regulation 3. The Scientific Advisory Board shall appoint one chairperson and one vice chairperson from among its members for a term of three years, renewable once. In duly justified situations, the majority of its members may request the chairperson and/or vice-chairperson to resign. 4. The Scientific Advisory Board shall establish its rules of procedure which shall, in particular, lay down procedures for: a) the functioning of expert panel; b) the appointment and replacement of its chairperson and vice-chairperson, c) the scientific assessment foreseen in Article 44, including in cases of urgency, The rules of procedure shall enter into force after receiving a favourable opinion from the Commission.
Amendment 746 #
Proposal for a regulation
Article 82 a (new)
Article 82 a (new)
Article 82 a Scientific advice 1. The Commission shall facilitate the access of manufacturers of innovative devices concerned by the scientific assessment laid down in Article 44 to scientific advice provided by the Scientific Advisory Board or by an EU reference laboratory to information concerning the criteria for an appropriate assessment of the conformity of a device, in particular with regard to the clinical data required for the clinical evaluation. 2. The scientific advice provided by the Scientific Advisory Board or by an EU reference laboratory shall not be binding. 3. The Commission shall publish summaries of the scientific advice referred to in paragraph 1, providing that all information of commercial confidential nature have been deleted.
Amendment 791 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.2 – point a a (new)
Annex 1 – part III – point 19 – point 19.2 – point a a (new)
(a a) the mention "This product is a medical device".
Amendment 800 #
Proposal for a regulation
Annex 6 – heading 1
Annex 6 – heading 1
Amendment 848 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
Annex 7 – part III – point 6 – point 6.7 – paragraph 1
All devices incorporating or consisting of nanomaterial are in class III unless the nanomaterial is encapsulated or bound in such a manner that it cannot beintended to be intentionally released into the patient's or user's body when the device is used within its intended purposehuman body are classified as class III.
Amendment 858 #
Proposal for a regulation
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Annex 7 – part III – point 6 – point 6.9 – paragraph 1
Devices that are composed of substances or combination of substances primarily intended to be ingested, inhaled or administered rectally or vaginally and that are absorbed by orand dispersed in the human body in order to achieve their intended purpose are in class III.
Amendment 867 #
Proposal for a regulation
Annex 8 – point 4 – point 4.4 – introductory part
Annex 8 – point 4 – point 4.4 – introductory part
4.4. The notified body shall randomly perform at least once every five years and for each manufacturer and generic device group unannounced factory inspections ato the relevant manufacturering sites and, if appropriate, ofat the manufacturer's suppliers and/or subcontractors, which may be combined with the periodic surveillance assessment referred toThe notified body shall establish a plan for the unannounced in Sspection 4.3. or be performed in addition to this surveillance assessment. The notified body shall establish a plan for the unannounced inspections which must not be disclosed to the manufacturers which must not be disclosed to the manufacturer. At the time of such inspections, the notified body shall carry out the tests or ask to carry them in order to check that the quality management system is working properly. It shall provide the manufacturer with an inspection report and with a test report.
Amendment 893 #
Proposal for a regulation
Annex 13 – point 5
Annex 13 – point 5
5. In the case of implantable devices and devices falling within class III, clinical investigations shall be performed unless it is duly justified to rely on existing clinical data alone. DFor novel products, demonstration of equivalence in accordance with Section 4 shall generally not be considered as sufficient justification within the meaning of the first sentence of this paragraph. However, for iteration of devices already on the market and for which clinical data are available and for which the data from the post-market surveillance are not indicating any safety concerns, demonstration of equivalence may be considered as a sufficient justification. For devices submitted to the scientific assessment foreseen in this Regulation, demonstration of equivalence shall be assessed by the MDCG.
Amendment 906 #
Proposal for a regulation
Annex 15 – point 4
Annex 15 – point 4
4. Equipment for liposuction and lipolysis;