Regulation EU (No) 722/2012 – New Regulation regarding medical devices utilizing tissues of animal origin

European Union Commission Regulation No 722/2012 concerning both active implantable medical devices (AIMD) and medical devices manufactured utilizing tissues of animal origin was originally published in the Official Journal of the European Union on 9th August 2012. The changes will apply from 29th August 2013. The Regulation replaces the existing requirements of directive 2003/32/EC and applies to both the AIMD and Medical Device Directives (90/385/EEC and 93/42/EEC respectively).

Background

In order for Member States to ensure that Notified Bodies under directives 90/385/EEC and 93/42/EEC have the necessary and up-to-date expertise, Notified Bodies have had to reapply for designation under the new regulation.

Manufacturers of existing AIMD utilizing non-viable animal tissue or derivatives (certified before 29th August 2013) must apply for complementary certification attesting compliance with the requirements laid out in Annex I of the new regulation; certificates must be issued by 29th August 2014 in order for those products to continue to be placed on the market in the European Union.

What changes must you consider?

  • Whilst the content of risk analysis and risk management requirements laid out in Annex I remain essentially unaffected, there are some key changes:
  • The directive has been replaced by a regulation which leaves no room for diverging transposition between member states.
  • The scope has been expanded to include products covered under the AIMD Directive.
  • Clarification has been provided that tallow derivatives (processed under conditions at least as vigorous as those laid down in Annex I) are excluded from the scope of the regulation.
  • There is no longer an exemption for medical devices using starting materials for which a TSE certificate of suitability has been issued. However the commenting period for these devices will be shortened from 12 weeks to 4 weeks. It should also be noted that Competent Authorities and the Commission may agree on further shortening of time periods.
  • There is increased emphasis on the collection of production and post-production information, for example regarding changes to sourcing, collection, handling, processing and inactivation or elimination, or the TSE risk relative to the device.
  • Any increase to the overall TSE risk will require reassessment by the Member States.

What does it mean for your business?

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.