21 Amendments of Thomas ULMER related to 2012/0267(COD)
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 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 111 #
Proposal for a regulation
Article 1 – paragraph 6
Article 1 – paragraph 6
6. This Regulation requires that certain devices may only be supplied on a medical prescription but shall not affect national laws which require that certain other devices may also only be supplied on a medical prescription. Direct to consumer advertising of devices classed as prescription only by this regulation shall be illegal. The following devices may only be supplied on a medical prescription: 1) Class D devices 2) Class C devices in the following categories: (a) devices for genetic testing; (b) companion diagnostics. The Commission shall be empowered to adopt delegated acts in accordance with Article 85 to decide on other category C tests after consultation with stakeholders.
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 144 #
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 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 177 #
Proposal for a regulation
Article 13 – paragraph 1 – point a
Article 13 – paragraph 1 – point a
(a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices;
Amendment 179 #
Proposal for a regulation
Article 13 – paragraph 1 – point b
Article 13 – paragraph 1 – point b
(b) fivetwo years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
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 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 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 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 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.