Activities of Gilles PARGNEAUX related to 2012/0266(COD)
Plenary speeches (2)
Medical devices - In vitro diagnostic medical devices (debate) FR
In vitro diagnostic medical devices - Medical devices (debate)
Amendments (22)
Amendment 178 #
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 pharmacists, and be compatible with the other authentication systems already in place in these environments.
Amendment 222 #
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 1
Article 1 – paragraph 1 – subparagraph 1
This Regulation establishes rules to be complied with by medical devices andfor human use, accessories to medical devices and medical devices for aesthetic purposes that are placed on the market or put into service in the Union for human use.
Amendment 223 #
Proposal for a regulation
Article 1 – paragraph 1 – subparagraph 2
Article 1 – paragraph 1 – subparagraph 2
For the purposes of this Regulation, medical devices and, accessories to medical devices and devices for aesthetic purposes shall hereinafter be referred to as ‘devices’.
Amendment 239 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2
Article 2 – paragraph 1 – subparagraph 1 – point 2
(2) ‘accessory to a medical device’ means an article which, whilst not being a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable or assist the device(s) to be used in accordance with its/their intended purpose(s);
Amendment 241 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
Article 2 – paragraph 1 – subparagraph 1 – point 2 a (new)
(2a) ‘device for aesthetic purposes’ means any instrument, apparatus, appliance, software, implant, material, substance or other article, intended by the manufacturer to be used, alone or in combination, for the purposes of modifying the physical appearance of human beings, without any therapeutic or reconstructive intent, by implanting it in the human body, attaching it to the surface of the eye or using it to induce a tissue or cell reaction on external or non- external parts of the human body. Tattooing products and piercings shall not be considered devices for aesthetic purposes.
Amendment 301 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 1
Article 8 – paragraph 6 – subparagraph 1
Proportionate to the risk class and the type of device, manufacturers of devices, other than custom-made 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’. Post-market surveillance assessments and reports shall be drawn up by independent bodies. 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 clinical follow-up in accordance with Part B of Annex XIII. Where post-market clinical follow-up is not deemed necessary, this shall be duly justified and documented in the post- market surveillance plan.
Amendment 305 #
Proposal for a regulation
Article 8 – paragraph 6 – subparagraph 2
Article 8 – paragraph 6 – subparagraph 2
If in the course of the post-market surveillance a need for corrective action is identified, the manufacturer shall implement the appropriate measures, including immediate notification to the European Databank on Medical Devices (Eudamed) established by means of Commission Decision 2010/227/EU of 19 April 2010.
Amendment 336 #
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, within the scope of their respective activities, 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.
Amendment 449 #
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) the compatibility with the other traceability systems used by actors working in the field of medical devices.
Amendment 457 #
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 summaryreport ofn safety and clinical performance that sets out all the findings of the clinical trials and studies. 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 42 and shall be validated by that body.
Amendment 475 #
Proposal for a regulation
Article 27 – paragraph 4
Article 27 – paragraph 4
4. All the information collated and processed by Eudamed shall be accessible to the Member States and to the Commission. The information shall be accessible to notified bodies, economic operators, sponsors, health professionals and the public to the extent defined in the provisions referred to in paragraph 2.
Amendment 505 #
Proposal for a regulation
Article 33 – paragraph 9
Article 33 – paragraph 9
9. Where no objection is raised in accordance with paragraph 7 or where the MDCG or the Commission, after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully or partially, the Commission shall publish the notification accordingly. The Commission shall also enter information on the notification of the notified body into the electronic system provided for in Article 27(2)(e). That information 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, as referred to in this article. The information held in the electronic system shall be accessible to the Member States and the Commission.
Amendment 512 #
Proposal for a regulation
Article 35 – paragraph 3
Article 35 – paragraph 3
3. At least once a year, the national authority responsible for notified bodies shall assess whether each notified body under its responsibility still satisfies the requirements set out in Annex VI. This assessment shall include an on-site visit to each notified body, and whether the body’s subsidiaries and subcontractors satisfy those requirements. This assessment shall include an on-site visit to each notified body, and to any subsidiaries or subcontractors it has, within or outside the Union.
Amendment 515 #
Proposal for a regulation
Article 35 – paragraph 4
Article 35 – paragraph 4
4. Three years after notification of a notified body, and again every third year thereafter, the assessment to determine whether the notified body still satisfies the requirements set out in Annex VI shall be conducted by the national authority responsible for notified bodies of the Member State in which the body is established and a joint assessment team designated in accordance with the procedure described in Article 32(3) and (4). At the request of the Commission or of a Member State, the MDCG may initiate the assessment process described in this paragraph at any time when there is reasonable concern about the ongoing compliance of a notified body or a subsidiary or subcontractor of a notified body with the requirements set out in Annex VI.
Amendment 519 #
Proposal for a regulation
Article 35 – paragraph 5 a (new)
Article 35 – paragraph 5 a (new)
5a. Every year, the notified bodies shall forward an annual activity report setting out the information referred to in Annex VI, point 5 to the competent authority under which they come and to the Commission, which shall forward it to the MDCG.
Amendment 521 #
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 2
Article 36 – paragraph 2 – subparagraph 2
The national authority responsible for notified bodies shall immediately inform the Commission and, the other Member States and the relevant manufacturers and health professionals of any suspension, restriction or withdrawal of a notification.
Amendment 523 #
Proposal for a regulation
Article 36 – paragraph 4
Article 36 – paragraph 4
4. The national authority responsible for notified bodies shall assess whether the reasons which gave rise to the change tosuspension, restriction or withdrawal of 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.
Amendment 524 #
Proposal for a regulation
Article 36 – paragraph 4
Article 36 – paragraph 4
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. With a view to ascertaining whether the reasons for the suspension, restriction or withdrawal of the notification have implications for the certificates issued, the national authority responsible shall ask the relevant manufacturers to supply evidence of conformity at notification, and the manufacturers shall have 30 days in which to respond to that request.
Amendment 625 #
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – 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 […/…] and the European Databank on Medical Devices (Eudamed) established under Commission Decision 2010/227/EU. With the exception of the information referred to in Article 52, the information collated and processed in the electronic system shall be accessible only to the Member States and to the Commission.
Amendment 636 #
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 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 668 #
Proposal for a regulation
Article 67 a (new)
Article 67 a (new)
Amendment 788 #
Proposal for a regulation
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point d
Annex 1 – part III – point 19 – point 19.1 – paragraph 1 – point d
(d) Labels shall be provided in a human- readable format but mayand shall be supplemented by machine-readable forms, such as radio- frequency identification (RFID) or bar codes.