The EU Regulation 722/2012 on AIMDD 90/385/EEC and MDD 93/42/EEC utilizing tissues of animal origin was published in the Official Journal L212 on 09 August 2012, entered into force on the 28 August 2012 and applicable from 29 August 2013. As a regulation, it does not need to be transposed into national legislations by the individual EU states.
The aim of the Regulation is to maintain a high level of safety in the European Market and to ensure health protection against the risk of transmitting animal spongiform encephalopathy to patients or other persons via medical devices. The Regulation sets out the aspects to be taken into account by manufacturers during their risk analysis and risk management in order to minimize that risk.
The main important changes
- The EU Regulation 722/2012 repeals Directive 2003/32/EC and the existing requirements under this Directive, regarding medical devices manufactured utilizing tissues of animal origin. It extends the scope by including active implantable medical devices under Directive AIMDD 90/385/EEC. It covers devices utilizing tissues of animal origin (non-viable tissues and tissue derivatives originating from bovine, ovine and caprine species, deer, elk, mink and cats) and links to Decision 2007/453 with respect to assessing the risk of the source country.
- The regulation reinforces the control of EU Notified Bodies. Member States shall verify that the Notified Bodies have up-to-date knowledge of the medical devices manufactured utilizing animal tissues. Member States must notify the Commission and other Member States the outcome of this control by 28 February 2013.
- The revised Annex 1 of the Regulation relating to Risk Analysis and Risk Management requires that manufacturers justify the use of animal tissue and take into consideration the classification of the risk.
- The manufacturer has an obligation to collect, evaluate and submit information to the Notified Body regarding changes to the animal tissue or derivatives used for the device or with regard to the TSE risk in relation to the device (section 8.0 of the non-binding MEDDEV). If the Notified Body concludes that such information result to an increase of the TSE risk, the conformity of the device concerned must be assessed again with the involvement of Member States competent authorities.
- Holders of EC design-examination certificates or EC type-examination certificates issued before 29 August 2013 for active implantable medical devices manufactured utilizing animal tissues must apply to their Notified Bodies for a complementary certificate attesting compliance with the new Regulation.
The CE Marking 93/68/EEC means European Conformity with all applicable EC Directives & Regulations.
As such, a Medical Device making use of tissues of animal origin, not taking the EU Regulation 722/2012 into account, shall not be able to bear the CE marking. Manufacturers should consult with their selected Notified Body or designated European Authorized Representative (EAR) for further advice on Regulation 722/2012.
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