Manufacturers of existing AIMD utilizing non-viable animal tissue / derivatives (certified before 29th August 2013)
Manufacturers of existing AIMD’s must carry out the risk analysis and risk management requirements set out in Annex I of the Regulation. BSI’s animal tissue experts will assess the documentation to verify the benefit/residual risk ratio, taking account of the justification for the use of animal tissues versus non-TSE susceptible species or synthetic alternatives. BSI will then submit for comments a summary evaluation report through the MHRA (the UK coordinating Competent Authority) to the Competent Authorities of the other Member States and the European Commission. BSI will consider any comments received before issuing complementary certification under 722/2012. This process must be complete before 29th August 2014.
Manufacturers of existing medical devices utilizing non-viable animal tissue / derivatives (certified before 29th August 2013)
It should be noted that although Directive 2003/32/EC will be repealed on 29th August 2013, existing design examination certificates referencing 2003/32/EC will remain valid; article 8 of Regulation 722/2012 confirms that references to the repealed directive are to be construed as references to the new Regulation.
Please continue to collect, evaluate and submit any information relating to changes impacting the animal tissue with regard to the TSE risk. It should be noted that any increase to the overall TSE risk will require a commenting period from Member States irrespective of whether a TSE Certificate of Suitability has been issued for the starting material.