[ParlTrack]

Proposal for a regulation
Article 4 – paragraph 5

~~5. The Commission shall be empowered to adopt~~ delegated acts in accordance with Article 89 amending or supplementing, in the light of technical progress and considering the intended users or patients, the general safety and performance requirements set out in Annex I, including the information supplied by the manufacturer.

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2

~~The Commission shall be empowered to adopt~~ delegated ~~acts in accordance with Article 89 amending or supplementing, in the light of technical progress, the elements in the technical documentation set out in Annex II.~~

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 24 – paragraph 1 a (new)

1a. It shall be updated with the results of the post-market clinical follow-up evaluation report referred to in Section 3 of Part B of Annex XIII.

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 29 – paragraph 2

~~2. The Commission shall be empowered to adopt~~ delegated acts in accordance with Article 89 amending or supplementing the minimum requirements in Annex VI, in the light of technical progress and considering the minimum requirements needed for the assessment of specific devices, or categories or groups of devices.

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 33 – paragraph 8

8. When a Member State or the Commission raises objections in accordance with paragraph 7, the ~~effect of the notification shall be suspended. In this case, the Commission shall bring the matter be~~Commission shall inforem the MDCG within 15 days after expiry of the period referred to in paragraph 7. After consulting the parties involved, the MDCG shall give its opinion at the latest within 2840 days after ~~the matter has been brought before it. If the notifying Member State does not agree with the opinion of the MDCG, it may request the Commission to give its opinion~~it has been informed.

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 33 – paragraph 9

9. Where no objection is raised in accordance with paragraph 7 or where the MDCG ~~or the Commission~~after having been consulted in accordance with paragraph 8, is of the opinion that the notification may be accepted fully, the Commission shall publish the notification accordingly. Where the MDCG, after having been consulted in accordance with paragraph 8, ~~is of the~~raises an objection in its opinion, th~~at the notification may be accepted fully or partially, the Commission shall publish the notification accordingly~~e notifying Member State shall provide a written response to the MDCG’s opinion within 28 days of its receipt. The response shall address the objections raised in the opinion, including the steps the notifying Member State intends to take to resolve the objections. The Commission shall publish the notification together with a summary of the MDCG’s opinion and the Member State response forthwith on receipt of the response.

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 41 – paragraph 4

4. In the light of technical progress and any information which becomes available in the course of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 as regards the following: (a) deciding that a device, or category or group of devices, should, by way of derogation from the classification criteria set out in Annex VII, be classified in another class; (b) amending or supplementing the classification criteria set out in Annex VII.deleted

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 42 – paragraph 11

11. In the light of technical progress and any information which becomes available in the course of the designation or monitoring of notified bodies set out in Articles 28 to 40, or of the vigilance and market surveillance activities described in Articles 61 to 75, the Commission shall be empowered to adopt delegated acts in accordance with Article 89 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI.deleted

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 44

Mechanism for scrutiny of certain 1. Notified bodies shall notify the Commission of applications conformity assessments for 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. 2. Within 28 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. Within 5 days after receipt of the request by the MDCG, the notified body shall inform the manufacturer thereof. 3. The MDCG may submit comments on the summary of the preliminary conformity assessment at the latest 60 days after submission of this summary. Within that period and at the latest 30 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. 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. 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 justification for not following the comments received, and its final decision regarding the conformity assessment in question. The Commission immediately transmit this information to the MDCG. 5. Where deemed necessary for the protection of patient safety and public health, the Commission, may determine, by means of implementing acts, specific categories or groups of devices, other than devices of class III, to which paragraphs 1 to 4 shall apply during a predefined period of time. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3). Measures pursuant to this paragraph may be justified only by one or more of the following criteria: (a) the novelty of the device or of the technology on which it is based and the significant clinical or public health impact thereof; (b) an adverse change in the risk-benefit profile of a specific category or group of devices due to scientifically valid health concerns in respect of components or source material or in respect of the impact on health in case of failure; (c) an increased rate of serious incidents reported in accordance with Article 61 in respect of a specific category or group of devices; (d) significant discrepancies in the conformity assessments carried out by different notified bodies on substantially similar devices; (e) public health concerns regarding a specific category or group of devices or the technology on which they are based. 6. The Commission shall make a summary of the comments submitted 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. 7. The Commission shall set up the technical infrastructure for the data- exchange by an electronic means between notified bodies and MDCG for the purposes of this Article. 8. The Commission, by means of implementing acts, may adopt the modalities and the procedural aspects concerning the submission and analysis of the summary of the preliminary conformity assessment in accordance with paragraphs 2 and 3. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 88(3).Article 44 deleted conformity assessments for Until any due shall

2013/05/17
Committee: IMCO

Ashley FOX

Proposal for a regulation
Article 49 – paragraph 5 – subparagraph 1 a (new)

For devices classified as class III and implantable devices, the summary of safety and clinical performance referred to in Article 26(1) shall be updated at least annually with clinical evaluation reports.

2013/05/17
Committee: IMCO

Activities of Ashley FOX related to 2012/0266(COD)

Shadow opinions (1)

Amendments (10)

ParlTrack - 2011-2024