Regulation 2012/722 - 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 - Main contents

EN

Official Journal of the European Union

L 212/3

Specific rules for medical devices manufactured utilising tissues of animal origin were initially adopted by Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (3). This Directive was applicable only to medical devices falling within the scope of Directive 93/42/EEC.

In order to maintain a high level of safety and health protection against the risk of transmitting animal spongiform encephalopathies to patients or other persons via medical devices manufactured utilising non-viable animal tissues or derivatives rendered non-viable, including custom-made devices and devices intended for clinical investigation, it is necessary to update the rules laid down in Directive 2003/32/EC on the basis of the experience with the application of this Directive and to apply them also to active implantable medical devices manufactured utilising tissues of animal origin that fall within the scope of Directive 90/385/EEC.

Taking into account that this measure lays down clear and detailed rules that do not give room for diverging transposition by Member States, a Regulation is the appropriate legal instrument which shall replace Directive 2003/32/EC.

Prior to being placed on the market or put into service, active implantable medical devices and medical devices of class III in accordance with the classification rules set out in Annex IX to Directive 93/42/EEC, whether they originate in the European Union or are imported from third countries, are subject to the conformity assessment procedures laid down in Article 9(1) of Directive 90/385/EEC and in Article 11(1) of Directive 93/42/EEC, respectively. Annex 1 to Directive 90/385/EEC and Annex I to Directive 93/42/EEC, respectively, set out the essential requirements that active implantable medical devices and other medical devices must meet in this regard.

With regard to active implantable medical devices and other medical devices manufactured utilising tissues of animal origin it is necessary to adopt more detailed specifications in relation to the requirements set out in point 6 of Annex 1 to Directive 90/385/EEC and points 8.1 and 8.2 of Annex I to Directive 93/42/EEC. Moreover, it is appropriate to specify certain aspects relating to the risk analysis and risk management in the framework of the conformity assessment procedures referred to in Article 9 of Directive 90/385/EEC and Article 11 of Directive 93/42/EEC, respectively.

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules concerning animal by-products not intended for human consumption (4) sets out provisions on the sourcing of materials used in medical devices. It is appropriate to lay down additional provisions on the use of such materials as starting tissue for the manufacture...