# 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), Division 1.2.3: Nature of starting tissue

Extent: E+W+S+N.I.

The manufacturer must take into account the classification of the risks relating to different types of starting tissue as defined in the WHO Guidelines on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies (2006), as amended. Sourcing of animal tissue must be performed in such a manner as to maintain control over the traceability and integrity of source tissue. Where appropriate, the animals shall be subjected to veterinary ante- and post-mortem inspection.
In addition, Regulation (EC) No 1069/2009 applies.
Without prejudice to the provision in the following paragraph, only category 3 material in accordance with Article 10 of Regulation (EC) No 1069/2009 shall be used.
The manufacturer must not source animal tissue or derivatives classified as potentially high TSE infective, unless sourcing of these materials is necessary in exceptional circumstances, taking into account the important benefit for the patient and the absence of an alternative starting tissue.
For bovine, ovine and caprine animals, the list of specified risk material (SRM) laid down in Annex V to Regulation (EC) No 999/2001 is to be considered as being potentially of high TSE infectivity.

---
Source: https://www.legislation.gov.uk/eur/2012/722/annex/I/division/1/division/1.2/division/1.2.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-1/division-1.2/division-1.2.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.