Activities of Rebecca TAYLOR related to 2012/0267(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices PDF (1 MB) DOC (1 MB)
Amendments (25)
Amendment 83 #
Proposal for a regulation
Recital 9 a (new)
Recital 9 a (new)
(9a) In the case of urgent or unmet medical needs for patients, such as emerging pathogens and rare diseases, single health institutions should have the possibility to manufacture, modify and use devices in-house and therefore address, within a non-commercial and flexible framework, specific needs which can not be met by an available CE- marked device.
Amendment 89 #
Proposal for a regulation
Recital 30
Recital 30
(30) 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 performance studies 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 102 #
Proposal for a regulation
Recital 49
Recital 49
(49) 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 112 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
Article 2 – paragraph 1 – subparagraph 1 – point 1 – indent 1
– diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Amendment 138 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 1
Article 4 – paragraph 5 – subparagraph 1
With the exception of Article 59(4), the requirements of this Regulation shall not apply to devices classified as class A, B and C, in accordance with the rules set out in Annex VII, and manufactured and used only within a single health institution, provided manufacture and use occur solely under the health institution’s single quality management system, and the health institution is compliant withaccredited to standard EN ISO 15189 or any other equivalent recognised standard. Member States may require that the health institutions submit to the competent authority a list of such devices which have been manufactured and used on their territory and may make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 141 #
Proposal for a regulation
Article 4 – paragraph 5 – subparagraph 2
Article 4 – paragraph 5 – subparagraph 2
Devices classified as class D in accordance with the rules set out in Annex VII, even if manufactured and used within a single health institution, shall comply withbe exempt from the requirements of this Regulation. However, the provis, with the exception of Article 59(4), where the following conditions aregarding met; (a) the recipient patient or patient group’s specific needs can not be met by an available CE -marking set out in Article 16 and the obligationsed device; (b) the health institution is accredited to EN ISO standard 15189 quality management system, or any other equivalent recognised standard; (c) the health institution provides their competent authority referred to in Articles 21 to 25 shall not apply to those devices6 with a list of such devices, which shall include a justification of their manufacturing or modification, in particular, where similar devices have been made available on the market. This information shall be updated yearly, and shall be made public.
Amendment 142 #
Proposal for a regulation
Article 4 – paragraph 5 a (new)
Article 4 – paragraph 5 a (new)
5a. Member States shall retain the right to restrict the in-house manufacture and use of any specific type of in-vitro diagnostic device in relation to aspects that are not covered by this Regulation, and may also make the manufacture and use of the devices concerned subject to further safety requirements.
Amendment 187 #
Proposal for a regulation
Article 22 – paragraph 2 – point e – point i
Article 22 – 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 194 #
Proposal for a regulation
Article 25 – paragraph 1
Article 25 – paragraph 1
The Commission shall develop and manage the European databank on medical devices (Eudamed) in accordance with the conditions and modalities established by Article 27 of Regulation (EU) [Ref. of future Regulation on medical devices]. The Commission shall consult patients groups and healthcare professionals when developing the European Databank
Amendment 224 #
Proposal for a regulation
Article 34 – paragraph 2 – subparagraph 1
Article 34 – 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 228 #
Proposal for a regulation
Article 35 – paragraph 3 – subparagraph 1
Article 35 – paragraph 3 – subparagraph 1
3. 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, in line with Article 34(2).
Amendment 229 #
Proposal for a regulation
Article 37 – paragraph 1
Article 37 – 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 the coordination group of notified bodies referred to in Article 39 of Regulation [Ref. of future Regulation on medical devices].
Amendment 231 #
Proposal for a regulation
Article 37 – paragraph 2 a (new)
Article 37 – paragraph 2 a (new)
The group shall meet, at the least, every 6 months
Amendment 232 #
Proposal for a regulation
Article 37 – paragraph 2 b (new)
Article 37 – paragraph 2 b (new)
The Commission or the MDCG may request the participation of any notified body.
Amendment 233 #
Proposal for a regulation
Article 37 – paragraph 2 c (new)
Article 37 – 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 294 #
Proposal for a regulation
Article 51 – paragraph 1 – point c a (new)
Article 51 – paragraph 1 – point c a (new)
(c a) the clinical performance study reports submitted by sponsors in Article 56(5);
Amendment 302 #
Proposal for a regulation
Article 55 – paragraph 3
Article 55 – paragraph 3
3. Within one year from the end of the clinical performance study, the sponsor shall submit to the Member States concerned a summary of the results of the clinical performance study in form of a clinical performance study report referred to in Section 2.3.3 of Part A of Annex XII. Where, for scientific reasons, it is not possible to submit the clinical performance study report within one year, it shall be submitted as soon as it is available. In this case, the clinical performance study protocol referred to in Section 2.3.2 of Part A of Annex XII shall specify when the results of the clinical performance study are going to be submitted, together with an explanation.
Amendment 310 #
Proposal for a regulation
Article 59 – paragraph 3 – subparagraph 1 a (new)
Article 59 – paragraph 3 – subparagraph 1 a (new)
The reporting of suspected serious incidents shall take into account whether parts or components have been replaced, as specified in Article 19.
Amendment 312 #
Proposal for a regulation
Article 60 – paragraph 1 – point f a (new)
Article 60 – paragraph 1 – point f a (new)
(f a) the reports by competent authorities on serious incidents and field safety corrective actions taken within Health Institutions involving devices referred to in Article 4(4)
Amendment 313 #
Proposal for a regulation
Article 60 – paragraph 2
Article 60 – 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 25.
Amendment 317 #
Proposal for a regulation
Article 66 – paragraph 2
Article 66 – 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 25.
Amendment 321 #
Proposal for a regulation
Article 77 – paragraph 1 – point a a (new)
Article 77 – paragraph 1 – point a a (new)
(aa) to oversee the coordination group of Notified Bodies as specified in Article 39;
Amendment 324 #
Proposal for a regulation
Article 77 – paragraph 1 – point b a (new)
Article 77 – paragraph 1 – point b a (new)
(ba) to act as an arbitration forum for disputes concerning Chapter IV on the competences of Notified Bodies.
Amendment 326 #
Proposal for a regulation
Article 77 – paragraph 1 – point d a (new)
Article 77 – paragraph 1 – point d a (new)
(da) to assist 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 75;
Amendment 356 #
Proposal for a regulation
Annex 2 – point 6 – paragraph 2 – point 6.1 – point 6.2 – paragraph 2
Annex 2 – point 6 – paragraph 2 – point 6.1 – point 6.2 – paragraph 2
The clinical evidence report referred to in Section 3 of Annex XII shall be included and/or fully referenced in the technical documentation.