Activities of Françoise GROSSETÊTE related to 2012/0266(COD)
Plenary speeches (2)
In vitro diagnostic medical devices - Medical devices (debate)
Medical devices - In vitro diagnostic medical devices (debate) FR
Amendments (11)
Amendment 169 #
Proposal for a regulation
Recital 31
Recital 31
(31) The findings of the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), established by Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC, in its scientific opinion of 15 April 2010 on the safety of reprocessed medical devices marketed for single-use, and of the Commission in its report of 27 August 2010 to the European Parliament and the Council on the issue of reprocessing of medical devices in the European Union, in accordance with Article 12a of Directive 93/42/EEC, call for regulation of the reprocessing of single- use devices in order to ensure a high level of protection of health and safety whilst allowing this practice to further develop under clear conditions. By reprocessing a single-use device its intended purpose is modified and the reprocessor should therefore be considered the manufacturer of the reprocessed device. The reprocessing of implantable single-use devices and surgically invasive single-use devices should be prohibited.
Amendment 177 #
Proposal for a regulation
Recital 34
Recital 34
(34) The traceability of 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 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 be compatible with the safety features as referred to in Directive 2011/62/EU.
Amendment 391 #
Proposal for a regulation
Article 15 – paragraph 3
Article 15 – paragraph 3
3. In the case of rReprocessing of implantable single-use devices for critical use, only reprocessing that is considered safe according to the latest scientific evidence may be carried outand surgically invasive single-use devices shall be prohibited.
Amendment 448 #
Proposal for a regulation
Article 24 – paragraph 8 – point e a (new)
Article 24 – paragraph 8 – point e a (new)
(ea) the compatibility of the UDI systems with the safety features established under Directive 2011/62/EU amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
Amendment 567 #
Proposal for a regulation
Article 44 – paragraph 1
Article 44 – paragraph 1
1. Notified bodies shall notify the Commission of applications for conformity assessments for implantable devices classified as class III, with the exception of applications to supplement or renew existing certificates. The notification shall be accompanied by the draft instructions for use referred to in Section 19.3 of Annex I and the draft summary of safety and clinical performance referred to in Article 26. In its notification the notified body shall indicate the estimated date by which the conformity assessment is to be completed. The Commission shall immediately transmit the notification and the accompanying documents to the MDCG.
Amendment 574 #
Proposal for a regulation
Article 44 – paragraph 2 – subparagraph 1
Article 44 – paragraph 2 – subparagraph 1
Within 280 days of receipt of the information referred to in paragraph 1, the MDCG may request the notified body to submit a summary of the preliminary conformity assessment prior to issuing a certificate. Upon suggestion by any of its members or by the Commission, the MDCG shall decide on making such request in accordance with the procedure set out in Article 78(4). In its request the MDCG shall indicate the scientifically valid health reason for having selected the specific file for submission of a summary of the preliminary conformity assessment. When selecting a specific file for submission, the principle of equal treatment shall be duly taken into account.
Amendment 581 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. The MDCG may submit commentsdeliver a favourable or unfavourable opinion on the summary of the preliminary conformity assessment at the latest 640 days after submission of this summary. If it does not deliver an opinion within those 40 days, its opinion shall be deemed favourable. Within that period and at the latest 320 days after submission, the MDCG may request the submission of additional information that for scientifically valid grounds are necessary for the analysis of the notified body's preliminary conformity assessment. This may include a request for samples or an on-site visit to the manufacturer's premises. Until submission of the additional information requested, the period for comments referred to in the first sentence of this subparagraph shall be suspended. Subsequent requests for additional information from the MDCG shall not suspend the period for the submission of comments.
Amendment 584 #
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
4. The notified body shall give due consideration to any comments received in accordance with paragraph 3. It shall convey to the Commission an explanation of how they have been taken into consideration, including any due justification for not following the comment’s final decision regarding the conformity assessment shall be subject to the opinion delivered under paragraph 3. The notified body may submit comments on the opinion to the Commission, which shall immediately transmit this information to the MDCG. If the opinion delivered under paragraph 3 is unfavourable, the notified body shall notify the manufacturer immediately and shall have 15 days from the date of receipt of the opinion in which to apply for a review. Within 30 days of receiving an application for review, the MDCG shall forward a final opinion to the notified body. The final opinion shall be accompanied by a report setting out the grounds on which its conclusions areceived, and based. If the opinion delivered under paragraph 3 its final decision regarding the conformity assessment in question. The Commission shall immediately transmit this information to the MDCGavourable, the notified body may proceed with certification. However, if the favourable opinion is dependent on specific measures (such as adjustments to the post-market clinical follow-up plan or certification with a time limit) being taken, the notified body shall issue a certificate of conformity only on condition that those measures are taken.
Amendment 591 #
Proposal for a regulation
Article 44 – paragraph 6
Article 44 – paragraph 6
6. The Commission shall make a summary of the comments submittopinions delivered in accordance with paragraph 3 and the outcome of the conformity assessment procedure accessible to the public. It shall not disclose any personal data or information of commercially confidential nature.
Amendment 635 #
Proposal for a regulation
Article 61 – paragraph 3 – subparagraph 1
Article 61 – 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 720 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
(b) to cmontribute itor the scrutiny of certain conformity assessments pursuant to Article 44;