Activities of Rebecca TAYLOR related to 2012/0266(COD)
Plenary speeches (1)
In vitro diagnostic medical devices - Medical devices (debate)
Amendments (22)
Amendment 182 #
Proposal for a regulation
Recital 37
Recital 37
(37) Eudamed's electronic systems regarding devices on the market, the relevant economic operators and certificates should enable the public to be adequately informed about devices on the Union market. The electronic system on clinical investigations should serve as tool for the cooperation between Member States and for enabling sponsors to submit, on a voluntary basis, a single application for several Member States and, in this case, to report serious adverse events. The electronic system on vigilance should enable manufacturers to report serious incidents and other reportable events and to support the coordination of their assessment by national competent authorities. The electronic system regarding market surveillance should be a tool for the exchange of information between competent authorities. A regular overview of vigilance and market surveillance information should be made available to healthcare professionals and the public
Amendment 204 #
Proposal for a regulation
Recital 53
Recital 53
(53) Healthcare professionals and patients should be empowered to report suspected serious incidents at national level using harmonised formats and guaranteeing anonymity, where appropriate. The national competent authorities should inform manufacturers and share the information with their peers when they confirm that a serious incident has occurred in order to minimise recurrence of those incidents.
Amendment 277 #
Proposal for a regulation
Article 3 – paragraph 1
Article 3 – paragraph 1
1. The Commission may, at the request of a Member State or on its own initiative, and following consultation with the MDCG, 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 387 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. Any natural or legal person who reprocesses a 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.comply with guidelines to be set out by the Commission by means of implementing acts, to ensure the safety of the reprocessing
Amendment 442 #
Proposal for a regulation
Article 24 – paragraph 2 – point e – point i
Article 24 – paragraph 2 – point e – point i
(i) to operate its system for the assignment of UDIs for the period to be determined in the designation which shall at least be threfive years after its designation;
Amendment 470 #
Proposal for a regulation
Article 27 – paragraph 1 – point c
Article 27 – paragraph 1 – point c
(c) to enable the public to be adequately informed about clinical investigations, for healthcare professionals to have adequate access to the results of clinical investigations, and to enable sponsors of clinical investigations to be conducted in more than one Member State to comply with information obligations under Articles 50 to 60;
Amendment 471 #
Proposal for a regulation
Article 27 – paragraph 1 – point c a (new)
Article 27 – paragraph 1 – point c a (new)
(ca) to enable the public and healthcare professionals to have an overview of vigilance data and market surveillance activities
Amendment 479 #
Proposal for a regulation
Article 27 – paragraph 4 a (new)
Article 27 – paragraph 4 a (new)
4a. The information contained in the European Databank shall be robust, transparent and user-friendly, enabling the public and healthcare professionals to compare information on registered devices, economic operators, clinical investigations, vigilance data and market- surveillance activities
Amendment 480 #
Proposal for a regulation
Article 27 – paragraph 4 b (new)
Article 27 – paragraph 4 b (new)
4b. The Commission shall consult patients groups and healthcare professionals when developing the European Databank.
Amendment 520 #
Proposal for a regulation
Article 36 – paragraph 2 – subparagraph 1
Article 36 – paragraph 2 – subparagraph 1
Where a national authority responsible for notified bodies has ascertained that a notified body no longer meets the requirements set out in Annex VI, or that it is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the notification, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. A sSuspension shall not exceed a period of one year, renewable once for the same periodapply until a decision to annul the suspension has been reached by the MDCG, which shall follow an assessment by a joint assessment team designated in accordance with the procedure described in Article 30(3) and (4). Where the notified body has ceased its activity, the national authority responsible for notified bodies shall withdraw the notification.
Amendment 526 #
Proposal for a regulation
Article 37 – paragraph 3 – subparagraph 1
Article 37 – paragraph 3 – subparagraph 1
Where the Commission ascertain, in consultation with the Medical Devices Coordination Group, decides that a notified body no longer meets the requirements for its notification, it shall inform the notifying Member State accordingly and request it to take the necessary corrective measures, including the suspension, restriction or withdrawal of the notification, if necessary. n line with Article 36(2).
Amendment 528 #
Proposal for a regulation
Article 39 – paragraph 1
Article 39 – paragraph 1
The Commission, in consultation with the Medical Devices Coordination Group, shall ensure that appropriate coordination and cooperation between notified bodies is put in place and operated in the form of a coordination group of notified bodies in the field of medical devices, including in vitro diagnostic medical devices.
Amendment 529 #
Proposal for a regulation
Article 39 – paragraph 2 a (new)
Article 39 – paragraph 2 a (new)
The group shall meet every 6 months
Amendment 530 #
Proposal for a regulation
Article 39 – paragraph 2 b (new)
Article 39 – paragraph 2 b (new)
Amendment 531 #
Proposal for a regulation
Article 39 – paragraph 2 c (new)
Article 39 – paragraph 2 c (new)
The Commission may, by means of implementing acts, adopt measures setting out the modalities for the functioning of the coordination group of notified bodies as set out in this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 84(3).
Amendment 624 #
Proposal for a regulation
Article 53 – paragraph 1 – point c a (new)
Article 53 – paragraph 1 – point c a (new)
(c a) the clinical investigation reports submitted by sponsors in Article 58(5)
Amendment 628 #
Proposal for a regulation
Article 57 – paragraph 3
Article 57 – paragraph 3
3. Within one year from the end of the clinical investigation, the sponsor shall submit to the Member States concerned a summary of the results of the clinical investigation in form of a clinical investigation report referred to in Section 2.7 of Chapter I of Annex XIV. Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year, it shall be submitted as soon as it is available. In this case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XIV shall specify when the results of the clinical investigation are going to be submitted, together with an explanation.
Amendment 645 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. The information collated and processed by the electronic system shall be accessible to the competent authorities of the Member States, to the Commission and to the notified bodies. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 27
Amendment 680 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. The information mentioned in paragraph 1 shall be immediately transmitted through the electronic system to all competent authorities concerned and be accessible to the Member States and to the Commission. The Commission, in consultation with the Medical Devices Coordination Group, shall provide an overview of this information, every 6 months, for the public and healthcare professionals. This information shall be accessible through the European databank in Article 27
Amendment 705 #
Proposal for a regulation
Article 78 – paragraph 5 a (new)
Article 78 – paragraph 5 a (new)
5 a. The MDCG shall oversee the coordination group of Notified Bodies as specified in Article 39
Amendment 709 #
Proposal for a regulation
Article 78 – paragraph 7 a (new)
Article 78 – paragraph 7 a (new)
7 a. The MDCG shall support the Commission in providing an overview of vigilance data and market surveillance activities, including any preventive health protection measures taken, on a 6- monthly basis. This information shall be accessible through the European databank in Article 27.
Amendment 710 #
Proposal for a regulation
Article 78 – paragraph 7 b (new)
Article 78 – paragraph 7 b (new)
7 b. The MDCG shall acts as an arbitration forum for disputes concerning Chapter IV on the competences of Notified Bodies.