Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin Text with EEA relevance

1 This Regulation lays down particular requirements in relation to the placing on the market and/or putting into service of medical devices, including active implantable medical devices, manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.

2 This Regulation shall apply to animal tissues, as well as their derivatives, originating from bovine, ovine and caprine species, deer, elk, mink and cats.

3 Collagen, gelatine and tallow used for the manufacturing of medical devices shall meet at least the requirements as fit for human consumption laid down in Regulation (EC) No 1069/2009.

4 This Regulation shall not apply to any of the following: (a) Tallow derivatives, processed under conditions at least as vigorous as those laid down in Section 3 of Annex I; (b) medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.

For the purposes of this Regulation, the following definitions apply in addition to the definitions set out in Directive 90/385/EEC and Directive 93/42/EEC: (a) ‘cell’ means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment; (b) ‘tissue’ means an organisation of cells, extra-cellular constituents or both; (c) ‘derivative’ means a material obtained from animal tissue through one or more treatments, transformations or steps of processing; (d) ‘non-viable’ means having no potential for metabolism or multiplication; (e) ‘TSEs’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001 of the European Parliament and of the Council ; (f) ‘TSE infectious agents’ means unclassified pathogenic agents which are capable of transmitting TSEs; (g) ‘reduction, elimination or removal’ means a process by which the number of TSE infectious agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction; (h) ‘inactivation’ means a process by which the ability to cause infection or pathogenic reaction by TSE infectious agents is reduced; (i) ‘source country’ means the country or countries in which the animal was born, has been reared and/or has been slaughtered; (j) ‘starting materials’ means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.

1 Before lodging an application for a conformity assessment pursuant to Article 9(1) of Directive 90/385/EEC or Article 11(1) of Directive 93/42/EEC, the manufacturer of medical devices referred to in Article 1(1) of this Regulation or his authorised representative shall carry out the risk analysis and risk management scheme set out in Annex I to this Regulation.

2 For custom-made devices and devices intended for clinical investigation which fall under Article 1(1), the statement of the manufacturer or his authorised representative and the documentation in accordance with Annex 6 to Directive 90/385/EEC or Annex VIII to Directive 93/42/EEC, respectively, shall also address compliance with the particular requirements set out in section 1 of Annex I to this Regulation.

1 Member States shall verify that bodies notified under Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and with the particular requirements laid down in Annex I to this Regulation. Member States shall regularly verify that those bodies maintain the required up-to-date knowledge and expertise. Where, on the basis of that verification, it is necessary for a Member State to amend the tasks of a notified body, that Member State shall notify the Commission and the other Member States accordingly.

2 The Member States shall inform the Commission and the other Member States regarding the outcome of the verification referred to in the first sentence of paragraph 1 by 28 February 2013.

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.

Without prejudice to Article 7(2), Member States shall take all necessary steps to ensure that medical devices referred to in Article 1(1) are placed on the market and/or put into service only if they comply with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and the particular requirements laid down in this Regulation.

1 Holders of EC design-examination certificates or EC type-examination certificates issued before 29 August 2013 for active implantable medical devices referred to in Article 1(1) shall apply to their notified body for a complementary EC design-examination certificate or EC type-examination certificate attesting compliance with the particular requirements laid down in Annex I to this Regulation.

2 Until 29 August 2014, Member States shall accept the placing on the market and the putting into service of active implantable medical devices referred to in Article 1(1) which are covered by an EC design-examination certificate or an EC type-examination certificate issued before 29 August 2013.

Directive 2003/32/EC is repealed with effect from 29 August 2013. References to the repealed Directive are to be construed as references to this Regulation.

This Regulation enters into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 29 August 2013 except for Article 4 which shall apply from the date of entry into force of this Regulation.