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19 Amendments of Mara BIZZOTTO related to 2012/0266(COD)

Amendment 28 #
Mara BIZZOTTO
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 45
(45) ‘corrective action’ means action taken to eliminate the cause of a potential or real non-conformity or other undesirable situationnon-conformities in order to prevent recurrence;
2013/04/26
Committee: EMPL
Amendment 30 #
Mara BIZZOTTO
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 46
(46) ‘fField sSafety cCorrective aAction’ means corrective (FSCA): A field safety corrective action is an action taken by thea manufacturer for technical or medical reasons to prevent orto reduce thea risk of adeath or serious incident in relation to a device made available on the marketdeterioration in the state of health associated with the use of a medical device;
2013/04/26
Committee: EMPL
Amendment 32 #
Mara BIZZOTTO
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 47
(47) ‘field safety notice’ means the: a communication sent by theout by a manufacturer to users or customor its representative to the device users in relation to a fField sSafety cCorrective aAction;
2013/04/26
Committee: EMPL
Amendment 37 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point a
(a) that the appropriate conformity assessment procedure has been carried out by the manufacturer;deleted
2013/04/26
Committee: EMPL
Amendment 38 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point b
(b) that an authorised representative in accordance with Article 9 has been designated by the manufacturer;deleted
2013/04/26
Committee: EMPL
Amendment 39 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point c
(c) that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer;deleted
2013/04/26
Committee: EMPL
Amendment 40 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point d
(d) that the device bears the required CE marking of conformity;deleted
2013/04/26
Committee: EMPL
Amendment 41 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point e
(e) that the device is labelled in accordance with this Regulation and accompanied by the required instructions for use and EU declaration of conformity;deleted
2013/04/26
Committee: EMPL
Amendment 42 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point f
(f) that, where applicable, a Unique Device Identification has been assigned by the manufacturer in accordance with Article 24.deleted
2013/04/26
Committee: EMPL
Amendment 43 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.deleted
2013/04/26
Committee: EMPL
Amendment 44 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 4
4. Importers shall ensure that the device is registered in the electronic system in accordance with Article 25(2).deleted
2013/04/26
Committee: EMPL
Amendment 45 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 6
6. When deemed appropriate with regard to the risks presented by a device, importers shall, in order to protect the health and safety of patients and users, carry out sample testing of marketed products, investigate complaints and keep a register of complaints, of non- conforming products and of product recalls and withdrawals, and shall keep the manufacturer, authorised representative and distributors informed of such monitoring.deleted
2013/04/26
Committee: EMPL
Amendment 46 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 7
7. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. 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 and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.deleted
2013/04/26
Committee: EMPL
Amendment 47 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 9
9. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 45, can be made available to those authorities, upon request. By written mandate, the importer and the authorised representative for the device in question may agree that this obligation is delegated to the authorised representative.deleted
2013/04/26
Committee: EMPL
Amendment 48 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 10
10. Importers shall, in response to a request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. This obligation shall be considered fulfilled when the authorised representative for the device in question provides the required information. Importers shall cooperate with a competent national authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market.deleted
2013/04/26
Committee: EMPL
Amendment 49 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 10 – point 1 (new)
(1) Importers operating under a mandate from the manufacturer 1. A manufacturer of a device that is placed on the Union market, or bears the CE marking without being placed on the Union market, who does not have a registered place of business in a Member State or does not carry out relevant activities at a registered place of business in a Member State, shall designate one or more importers. 2. The designation shall be valid only when accepted in writing by the importer. 3. The importer shall perform the tasks specified in the mandate agreed between the manufacturer and the importer. The mandate shall identify which of the following tasks are performed by which economic operator (manufacturer, Authorised representative, importer) in relation to the devices that it covers: (a) keeping the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate including any supplement issued in accordance with Article 45 at the disposal of competent authorities for the period referred to in Article 8(4); (b) in response to a reasoned request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device; (c) cooperate with the competent authorities on any corrective action taken to eliminate the risks posed by devices; (d) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated; (e) terminate the mandate if the manufacturer acts contrary to his obligations under this Regulation. (f) verification that the appropriate conformity assessment has been carried out, (g) verification that the device bears the required CE marking of conformity (h) verification that the device is labelled in accordance with this Regulation and accompanied by the required instructions for use and EU Declaration of Conformity (i) verification that, where applicable, a Unique Device Identification has been assigned by the manufacturer in accordance with Article 24 (j) registration of the device, the manufacturer, the authorised representative and the importer in the electronic system in accordance with Article 25 (k) sample testing of marketed products, investigation of complaints and keeping a register of complaints, of non-conforming products and of product recalls and withdrawals (l) when the importer or the manufacturer believes that a device that is placed on the market is not in conformity with this Regulation, the responsibility for actions to be taken to bring the device into conformity, withdraw or recall it, and notification to the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the noncompliance and of any corrective action taken (m) responsibility for, in response to a request from a competent national authority, provision of all the information and documentation necessary to demonstrate the conformity of a product. (n) communication with the manufacturer and authorised representative when importers are requested by a competent national authority, to cooperate on any action taken to eliminate the risks posed by products which they have placed on the market. 4. The mandate referred to in paragraph 3 shall not include the delegation of the manufacturer's obligations laid down in Article 8(1), (2), (5), (6), (7) and (8). 5. An importer who terminates the mandate on the grounds referred to in point (e) of paragraph 3 shall immediately inform the manufacturer and authorised representative of the termination of the mandate and the reasons thereof.
2013/04/26
Committee: EMPL
Amendment 50 #
Mara BIZZOTTO
Proposal for a regulation
Article 11 – paragraph 10 – point 2 (new)
(2) Importers operating without a mandate from the manufacturer 1. Before placing a device on the market importers shall ensure the following: (a) that the appropriate conformity assessment procedure has been carried out by the manufacturer; (b) that an authorised representative in accordance with Article 9 has been designated by the manufacturer; (c) that the EU declaration of conformity and the technical documentation has been drawn up by the manufacturer; (d) that the device bears the required CE marking of conformity; (e) that the device is labelled in accordance with this Regulation and accompanied by the required instructions for use and EU declaration of conformity; (f) that, where applicable, a Unique Device Identification has been assigned by the manufacturer in accordance with Article 24. 2. Importers shall indicate their name, registered trade name or registered trade mark and the address of their registered place of business at which they can be contacted and their location can be established on the device or on its packaging or in a document accompanying the device. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer. 3. Importers shall ensure that the device is registered in the electronic system in accordance with Article 25(2). 4. When deemed appropriate with regard to the risks presented by a device, importers shall, in order to protect the health and safety of patients and users, carry out sample testing of marketed products, investigate complaints and keep a register of complaints, of non- conforming products and of product recalls and withdrawals, and shall keep the manufacturer, authorised representative and distributors informed of such monitoring. 5. Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and his authorised representative and, if appropriate, take the necessary corrective action to bring that device into conformity, withdraw or recall it. 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 and, if applicable, the notified body that issued a certificate in accordance with Article 45 for the device in question, giving details, in particular, of the noncompliance and of any corrective action taken. 6. Importers shall, for the period referred to in Article 8(4), keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation and, if applicable, a copy of the relevant certificate including any supplement, issued in accordance with Article 45, can be made available to those authorities, upon request. By written mandate, the importer and the authorised representative for the device in question may agree that this obligation is delegated to the authorised representative. 7. Importers shall, in response to a request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of a product. This obligation shall be considered fulfilled when the authorised representative for the device in question provides the required information. Importers shall cooperate with a competent national authority, at its request, on any action taken to eliminate the risks posed by products which they have placed on the market. 8. Importers shall have available within their organisation at least one qualified person who possesses expert knowledge regarding the regulatory requirements for medical devices in the Union. The expert knowledge shall be demonstrated by either of the following qualifications: (a) a diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices; (b) five years of professional experience in regulatory affairs or in quality management systems relating to medical devices
2013/04/26
Committee: EMPL
Amendment 51 #
Mara BIZZOTTO
Proposal for a regulation
Article 44
1. Notified bodies shall notify the Commission of applications for 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. 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. 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 comments received, and its final decision regarding the conformity assessment in question. The Commission shall 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 Mechanism for scrutiny of certain conformity assessments
2013/04/26
Committee: EMPL
Amendment 53 #
Mara BIZZOTTO
Proposal for a regulation
Article 80 – paragraph 1 – point b
(b) to contribute to the scrutiny of certain conformity assessments pursuant to Article 44;deleted
2013/04/26
Committee: EMPL
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