Activities of Milan CABRNOCH 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)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
Amendments (22)
Amendment 17 #
Proposal for a regulation
Article 39 – paragraph 4 – introductory part
Article 39 – 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 59 to 73, the Commission, having consulted relevant stakeholders, including healthcare professionals’ organisations and manufacturers’ associations, shall be empowered to adopt delegated acts in accordance with Article 85 as regards the following:
Amendment 18 #
Proposal for a regulation
Article 42 – paragraph 6 a (new)
Article 42 – paragraph 6 a (new)
6a. Throughout the scrutiny process, the views of relevant stakeholders, including patient or healthcare professionals’ organisations and manufacturers’ associations, shall be taken into account.
Amendment 19 #
Proposal for a regulation
Article 61 – paragraph 1 – subparagraph 1
Article 61 – paragraph 1 – subparagraph 1
Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 59 is, at national level, evaluated centrally by their competent authority, if possible together with the manufacturer. The competent authority shall take into account the views of all relevant stakeholders, including patients, healthcare professionals’ organisations and manufacturers’ associations.
Amendment 20 #
Proposal for a regulation
Annex 1 – part III – point 17 – point 17.3 – point 17.3.2 – point i a (new)
Annex 1 – part III – point 17 – point 17.3 – point 17.3.2 – point i a (new)
(ia) The instructions for use shall be comprehensible to the layman and reviewed by the representatives of relevant stakeholders, including patients, healthcare professionals’ organisations and manufacturers’ associations.
Amendment 76 #
Proposal for a regulation
Recital 7 a (new)
Recital 7 a (new)
(7a) In situations in which a product is not conceived by its manufacturer to be used for medical purposes, its certification as an in vitro diagnostic medical device cannot be required; likewise a product cannot be an accessory to a specific in vitro diagnostic medical device if it is not specifically conceived by its manufacturer to enable or assist the intended purpose of the in vitro diagnostic medical device.
Amendment 113 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 3
Article 2 – paragraph 1 – subparagraph 1 – point 3
(3) ‘accessory to an in vitro diagnostic medical device’ means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically assist the medical functionality of the in vitro diagnostic medical device(s) in view of its/their intended purpose(s);
Amendment 114 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 4
Article 2 – paragraph 1 – subparagraph 1 – point 4
(4) ‘accessory to an in vitro diagnostic medical device’ means an article which, whilst not being an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable or assist the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically support the medical applications of the device(s) in respect of its/their intended purpose(s);
Amendment 124 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 22
Article 2 – paragraph 1 – subparagraph 3 – point 22
(22) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public healthand which has the legal capacity to carry out such activities;
Amendment 151 #
Proposal for a regulation
Article 8 – paragraph 2 – subparagraph 2
Article 8 – paragraph 2 – subparagraph 2
Amendment 153 #
Proposal for a regulation
Article 8 – paragraph 8
Article 8 – paragraph 8
8. Manufacturers 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 take the necessary corrective action to bring that product into conformity, withdraw it or recall it, as appropriate. They shall inform the distributors, importers and, where applicable, the authorised representative accordingly.
Amendment 162 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The designation shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.
Amendment 163 #
Proposal for a regulation
Article 9 – paragraph 3 – subparagraph 2 – point a
Article 9 – paragraph 3 – subparagraph 2 – point a
(a) keep a summary of 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 43 at the disposal of competent authorities for the period referred to in Article 8(4);
Amendment 164 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 1 – point a
Article 11 – paragraph 2 – subparagraph 1 – point a
(a) that the appropriatey shall verify that the conformity assessment procedure has been carried out by the manufacturer;
Amendment 165 #
Proposal for a regulation
Article 11 – paragraph 2 – subparagraph 2
Article 11 – paragraph 2 – subparagraph 2
Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not place the device on the market until it has been brought into conformity. Where the device or presents a risk, the importer shall inform the manufacturer and his authorised representative to that effect, as well as the competent authority of the Member State in which he is established, and shall only place the device on the market with the agreement of the manufacturer.
Amendment 166 #
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Importers shall indicate their name, registeensured 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 manufacturerhat their device is registered in the electronic system in accordance with Article 23(2).
Amendment 167 #
Proposal for a regulation
Article 11 – paragraph 5
Article 11 – paragraph 5
5. Importers shall ensure that, whileWhen deemed appropriate with regard to the risks presented by a device, is under their responsibility, storage or transport conditions do not jeopardimporters shall investigate and keep a register of complaints, of non-compliant products and of cases its compliance with the general safety and performance requirements set out in Annex I. n which a product is withdrawn from the market or from circulation, and shall notify the manufacturer, the authorised representative and the distributors of this.
Amendment 168 #
Proposal for a regulation
Article 11 – paragraph 6
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 monitoringManufacturers 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 inform the manufacturer and the authorised representative. 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 43 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.
Amendment 172 #
Proposal for a regulation
Article 12 – paragraph 2 – subparagraph 2
Article 12 – paragraph 2 – subparagraph 2
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, he shall not make the device available on the market until it has been brought into conformity. Where the device or presents a risk, the distributor shall inform the manufacturer and, where applicable, his authorised representative and the importer to that effect, as well as the competent authority of the Member State in which he is established, and shall only place the device on the market with the agreement of the manufacturer.
Amendment 175 #
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. Distributors shall, in response to a request from a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of a device. This obligation shall be considered fulfilled when the authorised representative for the device in question, where applicable, provides the required information. Distributors shall cooperate with competent national authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market.
Amendment 185 #
Proposal for a regulation
Article 21 – paragraph 1 – introductory part
Article 21 – paragraph 1 – introductory part
For devices, other than devices for performance evaluation, economic operators shall be able to identify the following, for thea period referred to in Article 8(4)of 10 years:
Amendment 269 #
Proposal for a regulation
Article 42
Article 42
Article deleted
Amendment 274 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
1. 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 XI.