Article 5
1
Conformity assessment procedures for medical devices referred to in Article 1(1) shall include the evaluation of compliance of the devices with the essential requirements of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and the particular requirements laid down in Annex I to this Regulation.
2
Notified bodies shall assess the documentation submitted by the manufacturer to verify that the benefits of the device outweigh the residual risks. Particular account shall be taken of:
a
the manufacturer’s risk analysis and risk management process;
b
the justification for the use of animal tissues or derivatives, taking into consideration lower risk tissues or synthetic alternatives;
c
the results of elimination and inactivation studies or results of the analysis of relevant literature;
d
the manufacturer’s control of the sources of raw materials, finished products, production process, testing, and subcontractors;
e
the need to audit matters related to the sourcing and processing of animal tissues and derivatives, processes to eliminate or inactivate pathogens, including those activities carried out by suppliers.
3
Notified bodies shall, during the evaluation of the risk analysis and risk management in the framework of the conformity assessment procedure, take account of the TSE certificate of suitability issued by the European Directorate for the Quality of Medicines, hereinafter ‘TSE certificate of suitability’, for starting materials, where available.
Where additional information is necessary to assess the suitability of the starting material for a given medical device, notified bodies may require submission of additional information to allow the evaluation as set out in paragraphs 1 and 2.
4
Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall, through their competent authority, hereinafter ‘coordinating competent authority’, inform the competent authorities of the other Member States and the Commission of their assessment carried out pursuant to paragraph 2 by means of a summary evaluation report in accordance with Annex II to this Regulation.
5
The competent authorities of the Member States may submit comments on the summary evaluation report referred to in paragraph 4 within the following deadlines:
a
in relation to medical devices using starting materials for which a TSE certificate of suitability as referred to in paragraph 3 has been submitted, within four weeks from the date on which the notified body informed the coordinating competent authority pursuant to paragraph 4;
b
in relation to medical devices using starting materials for which a TSE certificate of suitability has not been submitted, within 12 weeks from the date on which the notified body informed the coordinating competent authority pursuant to paragraph 4.
The competent authorities of the Member States and the Commission may agree on shortening the time periods set out in points (a) and (b).
6
The notified bodies shall give due consideration to any comments received in accordance with paragraph 5. They shall convey an explanation as regards this consideration, including any due justification not to take account of one or more of the comments received, and their final decisions to the coordinating competent authority, which shall then make these available to the Commission and the competent authorities from which comments were received.
7
The manufacturer shall collect, evaluate and submit to the notified body information regarding changes with regard to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device. Where such information leads to an increase of the overall TSE risk, the provisions of paragraphs 1-6 are applicable.