19 Amendments of Anja WEISGERBER related to 2012/0267(COD)
Amendment 48 #
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, pharmacies and wholesalers. The UDI system should be compatible with other systems already on the market.
Amendment 66 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 67 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(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);
Amendment 68 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively11(3).
Amendment 69 #
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, 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.
Amendment 72 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with medical device identification systems already on the market.
Amendment 85 #
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, pharmacies and in wholesale. The UDI system should be compatible with other systems which are already on the market.
Amendment 143 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Amendment 169 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Article 12 – paragraph 2 – subparagraph 1 – introductory part
Before making a device available on the market for the first time, distributors shall verify that the following requirements are met:
Amendment 170 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point b
Article 12 – paragraph 2 – subparagraph 1 – point b
(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);
Amendment 171 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 22 and Article 11(3) respectively11(3).
Amendment 173 #
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, 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.
Amendment 188 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with medical device identification systems already on the market.
Amendment 270 #
Proposal for a regulation
Article 42
Article 42
Article deleted
Amendment 323 #
Proposal for a regulation
Article 77 – paragraph 1 – point b
Article 77 – paragraph 1 – point b
Amendment 325 #
Proposal for a regulation
Article 77 – paragraph 1 – point c
Article 77 – paragraph 1 – point c
(c) to contribute to the development of guidance aimed at ensuring effective and harmonised implementation of this Regulation, in particular regarding the designation and monitoring of notified bodies, application of the general safety and performance requirements and conduct of the clinical evaluation by manufacturers and the assessment by notified bodies;.
Amendment 327 #
Proposal for a regulation
Article 77 – paragraph 1 – point e
Article 77 – paragraph 1 – point e
Amendment 328 #
Proposal for a regulation
Article 77 – paragraph 1 – point f
Article 77 – paragraph 1 – point f
Amendment 329 #
Proposal for a regulation
Article 77 – paragraph 1 – points f a to f k (new)
Article 77 – paragraph 1 – points f a to f k (new)
(fa) to continuously monitor the technical progress in particular in the field of implantable devices and assess whether the essential requirements on safety and performance provided within this Regulation are appropriate to ensure safety and performance of medical devices and identify the need to amend Annex I; (fb) to develop guidelines on clinical trials of certain medical devices (fc) to contribute to the development of medical devices standards; (fd) to contribute to the development of Common Technical Specifications (CTS) (fe) to develop and maintain a framework for a European market surveillance program; (ff) to develop minimum requirements on a quality management system for national market surveillance authorities . (fg) to organise joint market surveillance and joint testing projects; (fh) to organise training programmes and exchanges of national officials on market surveillance, on notified bodies designation and monitoring and on clinical investigations; (fi) to organise information campaigns and joint visit programmes; (fj) to provide an opinion on the application of the classification criteria set out in Annex VII to a given device, or category or group of devices according to Article 41 paragraph 3 within six months; (fk) to provide at the Commission's request an opinion on a the classification of a device, or category or group of devices according to Article 41 paragraph 4.