8 Amendments of Nora BERRA related to 2012/0267(COD)
Amendment 49 #
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, and, where possible, the system should be compatible with the other authentication systems already in place in such environments.
Amendment 52 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 6
Article 2 – paragraph 1 – subparagraph 1 – point 6
(6) ‘companion diagnostic’ means a device specifically intended to and essential in selecting patients with a previously diagnosed condition or predisposition as suitable or not suitable eligible for a targeted therapy with a medicinal product or a range of medicinal products;
Amendment 62 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2 a (new)
Article 4 – paragraph 5 – subparagraph 2 a (new)
In addition, devices classified as class D and required to be used for transfusion or transplantation purposes, when not available as CE marked, or available as CE marked but not reaching the appropriate standards or specifications required by the users, may be manufactured and used within a single health institution without fulfilling the requirements of this Regulation, provided they comply with the conditions defined in the first subparagraph, and the essential requirements (Annex I), and applicable harmonized standards (Article 6), and applicable common technical specifications (Article 7).
Amendment 73 #
Proposal for a regulation
Article 22 – paragraph 8 – point e a (new)
Article 22 – paragraph 8 – point e a (new)
(ea) compatibility with the other traceability systems used by medical device stakeholders.
Amendment 99 #
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 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 106 #
Proposal for a regulation
Annex 8 – section 2 – point 6 – point 6.2 – point e
Annex 8 – section 2 – point 6 – point 6.2 – point e
(e) The notified body shall give due consideration to the opinion, if any, expressed by the medicinal products competent authority concerned or the EMA when making its decision. It shall convef the notified body deviates from that position, it shall justify its final decision to the medicinal products competent authority concerned or to the EMA. If no compromise is reached, the matter shall be referred to the MDCG. The design-examination certificate shall be delivered in accordance with point (d) of Section 6.1.
Amendment 132 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 48
Article 2 – paragraph 1 – subparagraph 5 – point 48
(48) ‘device deficiency’ means any inadequacy in the identity, quality, durstability, reliability, safety or performance of a device for performance evaluation, including malfunction, use errors or inadequacy in the information supplied by the manufacturer;
Amendment 335 #
Proposal for a regulation
Article 78 – paragraph 2 – point i
Article 78 – paragraph 2 – point i
(i) to contribute to the development of standards atcommon technical specifications (CTS) as well as of international level;standards