Activities of Antonyia PARVANOVA related to 2012/0267(COD)
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 (16)
Amendment 53 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 21
Article 2 – paragraph 1 – subparagraph 1 – point 21
(21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health, with the exclusion of laboratories providing commercial clinical services;
Amendment 57 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 1 – point 45
Article 2 – paragraph 1 – subparagraph 1 – point 45
(45) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation and, management or financing of a clinical performance study;
Amendment 64 #
Proposal for a regulation
Article 8 – paragraph 7 – subparagraph 2
Article 8 – paragraph 7 – subparagraph 2
For devices for self-testing or near-patient- testing, the information supplied in accordance with Section 17 of Annex I shall be easily understandable and provided in the language(s) of the Member State where the device reaches its intended user.
Amendment 65 #
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 responsible national competent authority, the distributors and, where applicable, the authorised representative accordingly.
Amendment 74 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. It shall be made publicly available and written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 40 and shall be validated by that body.
Amendment 95 #
Proposal for a regulation
Article 57 – paragraph 2 – subparagraph 1 – point a
Article 57 – paragraph 2 – subparagraph 1 – point a
(a) a seriousny adverse event that has a causal relationship with the device for performance evaluation, the comparator or the study procedure or where such causal relationship is reasonably possible;
Amendment 97 #
Proposal for a regulation
Article 59 – paragraph 1 – subparagraph 1 – point a
Article 59 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 102 #
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented and sufficiently dissuasive. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.
Amendment 123 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 3 – point 21
Article 2 – paragraph 1 – subparagraph 3 – point 21
(21) ‘health institution’ means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health, with the exclusion of laboratories providing commercial clinical services;
Amendment 130 #
Proposal for a regulation
Article 2 – paragraph 1 – subparagraph 5 – point 45
Article 2 – paragraph 1 – subparagraph 5 – point 45
(45) ‘sponsor’ means any individual, company, institution or organisation which takes responsibility for the initiation and, management or financing of a clinical performance study;
Amendment 152 #
Proposal for a regulation
Article 8 – paragraph 7 – subparagraph 2
Article 8 – paragraph 7 – subparagraph 2
For devices for self-testing or near-patient- testing, the information supplied in accordance with Section 17 of Annex I shall be easily understandable and provided in the language(s) of the Member State where the device reaches its intended user.
Amendment 154 #
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 responsible national competent authority, the distributors and, where applicable, the authorised representative accordingly.
Amendment 192 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. In the case of devices classified as class C and D, other than devices for performance evaluation, the manufacturer shall draw up a summary of safety and performance. It shall be made publicly available and written in a way that is clear to the intended user. The draft of this summary shall be part of the documentation to be submitted to the notified body involved in the conformity assessment in accordance with Article 40 and shall be validated by that body.
Amendment 304 #
Proposal for a regulation
Article 57 – paragraph 2 – subparagraph 1 – point a
Article 57 – paragraph 2 – subparagraph 1 – point a
(a) a seriousny adverse event that has a causal relationship with the device for performance evaluation, the comparator or the study procedure or where such causal relationship is reasonably possible;
Amendment 307 #
Proposal for a regulation
Article 59 – paragraph 1 – subparagraph 1 – point a
Article 59 – paragraph 1 – subparagraph 1 – point a
(a) any serious incident in respect of devices made available on the Union market;
Amendment 341 #
Proposal for a regulation
Article 83 – paragraph 1
Article 83 – paragraph 1
The Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented and sufficiently dissuasive. The penalties provided for shall be effective, proportionate, and dissuasive. The Member States shall notify those provisions to the Commission by [3 months prior to the date of application of this Regulation] and shall notify it without delay of any subsequent amendment affecting them.