S.L. 427.44 Art. 7Conformity assessment for medical devices manufactured utilising tissues of animal origin.

(1) With respect to medical devices referred to in the definition for "medical device manufactured utilising tissues of animal origin" in article 3, the following regulations shall apply in addition to the provisions mentioned in regulation 6(1) to (12) that apply to them.

(2) Collagen, gelatine or tallow used for the manufacturing of medical devices, shall meet at least the requirements as fit for human consumption.

(3) All necessary steps shall be taken to ensure that devices referred to in the definition in sub-regulation (1) are placed on the market and put into service only if they comply with the provisions of these regulations and the specifications laid down in Schedule XIII.

(4) Conformity assessment procedures for medical devices referred to in the definition in sub-regulation (1) shall include the evaluation of their compliance with the essential requirements laid down in Schedule I and the specifications laid down in Schedule XIII.

(5) Before lodging an application for a conformity assessment pursuant to regulation 6(1), the manufacturer of medical devices referred to in the definition in sub-regulation (1) shall carry out the risk analysis and the risk management scheme set out in Schedule XIII.

(6) In order to assess the conformity of devices referred to the definition in sub-regulation (1) with the provisions of these regulations and with the specifications laid down in Schedule XIII, the Medicines Authority shall verify that bodies notified under regulations 13(1) to (8) have up-to-date knowledge of these devices. If, on the basis of that verification, it is necessary to amend the tasks of a notified body, the Medicines Authority shall notify the Commission and other Member States accordingly.

(7) Notified bodies shall evaluate the manufacturer’s risk analysis and risk management strategy, and in particular:

(a) the information provided by the manufacturer;

(b) the justification for the use of animal tissues or derivatives;

(c) the results of elimination and, or inactivation studies or of literature search;

(d) the manufacturer’s control of the sources of raw materials, finished products and subcontractors;

(e) the need to audit matters related to sourcing, including third party supplies.

(8) 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 referred to in the definition for "TSE certificate" in article 3, for starting materials, where available.

(9) Except for medical devices using starting materials for which a TSE certificate has been issued as referred to in sub-regulation (8), national bodies shall, through the Regulatory Affairs Directorate, seek the opinion of the competent authorities of the other Member States on their evaluation of and conclusions on the risk analysis and risk management of the tissues or the derivatives intended to be incorporated in the medical device as established by the manufacturer.

(10) Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall give due consideration to any comments received within twelve weeks from the date on which the opinion of the national competent authorities was sought.