32 Amendments of Philippe JUVIN related to 2012/0266(COD)
Amendment 194 #
Proposal for a regulation
Recital 44
Recital 44
(44) The conformity assessment procedure for class I devices should be carried out, as a general rule, under the sole responsibility of the manufacturers in view of the low level of vulnerability associated with these products. For medical devices in classes IIa, IIb and III, an appropriate level of involvement ofclose monitoring by a notified body should be compulsory, with medical devices in class III requiring explicit prior approval of their design and manufacture before they can be placed on the market.
Amendment 195 #
Proposal for a regulation
Recital 45
Recital 45
(45) The conformity assessment procedures should be simplifitrengthened and streamlined whilst the requirements for notified bodies as regards the performance of their assessments should be clearly specified to ensure a level playing field.
Amendment 335 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 1 – point c
Article 12 – paragraph 2 – subparagraph 1 – point c
(c) the manufacturer and, where applicable, the importer have complied with the requirements set out in Article 24 and Article 11(3) respectively11(3) and whether the product in question contains a UDI, as referred to in Article 24(1)(a).
Amendment 340 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. Distributors who consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, his authorised representative and the importer and make sure, the importer and the notified body responsible for monitoring the product if it is a class IIa, IIb or III medical device, and the competent national authority. They shall make sure, within the scope of their respective activities, that the necessary corrective action to bring that device into conformity, withdraw or recall it, if appropriate, is taken. Where the device presents a risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available, as well as the notified body responsible for evaluating the device if it is a class IIa, IIb or III product, giving details, in particular, of the non- compliance and of any corrective action taken.
Amendment 538 #
Proposal for a regulation
Article 41 – paragraph 4 – introductory part
Article 41 – paragraph 4 – introductory part
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 delegatedimplementing acts in accordance with Article 898 as regards the following:
Amendment 552 #
Proposal for a regulation
Article 42 – paragraph 11
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 delegatedimplementing acts in accordance with Article 898 amending or supplementing the conformity assessment procedures set out in Annexes VIII to XI.
Amendment 554 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of his choice, provided that the body is notified for the conformity assessment activities, the conformity assessment procedures and the devices concerned. An application may not be lodged in parallel with more than one notified body for the same conformity assessment activity. The manufacturer shall forward the name of the notified body he has chosen to the competent national authority of the Member State in which he has his head office.
Amendment 555 #
Proposal for a regulation
Article 43 – paragraph 2
Article 43 – paragraph 2
2. The notified body concerned shall inform the other notified bodies of any manufacturer who withdraws his application prior to the notified body's decision regarding the conformity assessment. It shall also inform all of the competent national bodies without delay.
Amendment 556 #
Proposal for a regulation
Article 43 – paragraph 4 a (new)
Article 43 – paragraph 4 a (new)
4a. At all of the stages in the conformity assessment procedure, the notified assessment body shall carry out at least one unannounced inspection at the manufacturer’s production facilities before making a decision on conformity. An unannounced inspection is one is which the manufacturer is given no advance notice of possible inspection dates and times. The notified body shall inform the competent authority of the Member State concerned of the findings of this inspection.
Amendment 566 #
Proposal for a regulation
Article 44 – title
Article 44 – title
Amendment 572 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 579 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
Amendment 583 #
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
Amendment 589 #
Proposal for a regulation
Article 44 – paragraph 5 – subparagraph 1
Article 44 – paragraph 5 – subparagraph 1
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).
Amendment 593 #
Proposal for a regulation
Article 44 – paragraph 7
Article 44 – paragraph 7
7. The Commission shall set up the technical infrastructure for the data- exchange by an electronic means between itself, notified bodies and MDCG for the purposes of this Article.
Amendment 594 #
Proposal for a regulation
Article 44 – paragraph 8
Article 44 – paragraph 8
Amendment 600 #
Proposal for a regulation
Article 45 – paragraph 1
Article 45 – paragraph 1
1. Before issuing a certificate, the notified conformity assessment body shall take into account any findings set out in the clinical investigation report referred to in paragraph 59(4) of this Regulation. The certificates issued by the notified bodies in accordance with Annexes VIII, IX and X shall be in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language acceptable to the notified body. The minimum content of the certificates is set out in Annex XII.
Amendment 601 #
Proposal for a regulation
Article 45 – paragraph 2 a (new)
Article 45 – paragraph 2 a (new)
2a. During the certificate of conformity’s period of validity, the relevant notified body shall conduct, at least once a year, unannounced inspections at the place of manufacture of the medical device it is responsible for assessing. An unannounced inspection is one is which the manufacturer is given no advance notice of possible inspection dates and times.
Amendment 602 #
Proposal for a regulation
Article 45 – paragraph 3
Article 45 – paragraph 3
3. Where a notified body finds that requirements of this Regulation are no longer met by the manufacturer, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or impose any restrictions on it unless compliance with such requirements is ensured by appropriate corrective action taken by the manufacturer within an appropriate deadline set by the notified body. The notified body shall give the reasons for its decision. and shall notify them to the competent authorities of the Member States in which the medical device is manufactured and placed on the market, the Commission and the MDCG.
Amendment 603 #
Proposal for a regulation
Article 45 – paragraph 5
Article 45 – paragraph 5
5. In the light of technical progress, the Commission shall be empowered to adopt delegatedimplementing acts in accordance with Article 898 amending or supplementing the minimum content of the certificates set out in Annex XII.
Amendment 604 #
Proposal for a regulation
Article 46 – paragraph 2 a (new)
Article 46 – paragraph 2 a (new)
2a. It shall notify the competent authorities of the Member States affected by the manufacture and placing on the market of the relevant medical device, the Commission and the MDCG.
Amendment 606 #
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. The Member State shall inform the Commission, the notified body responsible for assessing the relevant medical device, the MDCG and the other Member States of any decision to authorise the placing on the market or putting into service of a device in accordance with paragraph 1 where such authorisation is granted for use other than for a single patient.
Amendment 619 #
Proposal for a regulation
Article 51 – paragraph 6 – subparagraph 1
Article 51 – paragraph 6 – subparagraph 1
Member States shall ensure that the persons assessing the application do not have conflicts of interest and that they are independent of the sponsor, the institution of the investigation site(s)are independent of the sponsor and the investigators involved, as well as free of any other undue influence.
Amendment 622 #
Proposal for a regulation
Article 51 – paragraph 7
Article 51 – paragraph 7
7. The Commission shall be empowered to adopt delegatedimplementing acts in accordance with Article 898 amending or supplementing, in the light of technical progress and global regulatory developments, the requirements for the documentation to be submitted with the application for the clinical investigation that is laid down in Chapter II of Annex XIV.
Amendment 627 #
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. The Commission shall be empowered to adopt delegatedimplementing acts in accordance with Article 898 determining which other information regarding clinical investigations collated and processed in the electronic system shall be publicly accessible to allow interoperability with the EU database for clinical trials on medicinal products for human use set up by Regulation (EU) No […/…]. Article 52(3) and (4) shall apply.
Amendment 682 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
Where the competent authorities of a Member State, based on vigilance data or other information, have sufficient reason to believe that a device presents a risk to the health or safety of patients, users or other persons, they shall carry out an evaluation in relation to the device concerned covering all the requirements laid down in this Regulation that are relevant to the risk presented by the device. The relevant economic operators shall cooperate as necessary with the competent authorities. In connection with that evaluation, the competent authorities shall inform the notified assessment bodies, in the case of class IIa, IIb and III devices, and the other competent authorities of the findings of the evaluation and the measures that are to be taken on the basis of those findings.
Amendment 719 #
Proposal for a regulation
Article 80 – paragraph 1 – point b
Article 80 – paragraph 1 – point b
Amendment 751 #
Proposal for a regulation
Article 89 – paragraph 1
Article 89 – paragraph 1
1. The power to adopt the delegated acts referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) is conferred on the Commission subject to the conditions laid down in this Article.
Amendment 753 #
Proposal for a regulation
Article 89 – paragraph 2
Article 89 – paragraph 2
2. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.
Amendment 754 #
Proposal for a regulation
Article 89 – paragraph 3
Article 89 – paragraph 3
3. The delegation of power referred to in Articles 2(2) and (3), 4(5), 8(2), 17(4), 24(7), 25(7), 29(2), 40(2), 41(4), 42(11), 45(5), 51(7), 53(3), 74(4) and 81(6) may be revoked at any time by the European Parliament or by the Council. A decision of revocation shall put an end to the delegation of the power specified in that decision. It shall take effect the day following itsthe publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 812 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2
This presupposes the availability within its organisation of sufficient scientific personnel who possess experience, and university degree and the knowledge sufficientrequired to assess the medical functionality and performance of devices for which it has been notified, having regard to the requirements of this Regulation and, in particular, those set out in Annex I.
Amendment 813 #
Proposal for a regulation
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2 a (new)
Annex 6 – point 3 – point 3.1 – point 3.1.1 – paragraph 2 a (new)
The personnel responsible for carrying out the assessment tasks shall conduct unannounced inspections at least once a year of all premises at which the medical devices coming within their remit are manufactured. An unannounced inspection is one is which the manufacturer is given no advance notice of possible inspection dates and times. The personnel responsible for carrying out the assessment tasks shall notify all the competent authorities of the Member States affected by the manufacture and placing on the market of the medical device of the findings of the annual inspections carried out. Those findings shall be set out in a report. It shall also forward a record of the annual inspections carried out to the relevant national authority responsible.