Article 1
1
This Regulation lays down particular requirements in relation to the placing on the market and/or putting into service of medical devices, including active implantable medical devices, manufactured utilising animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
2
This Regulation shall apply to animal tissues, as well as their derivatives, originating from bovine, ovine and caprine species, deer, elk, mink and cats.
3
Collagen, gelatine and tallow used for the manufacturing of medical devices shall meet at least the requirements as fit for human consumption laid down in Regulation (EC) No 1069/2009.
4
This Regulation shall not apply to any of the following:
a
Tallow derivatives, processed under conditions at least as vigorous as those laid down in Section 3 of Annex I;
b
medical devices referred to in paragraph 1, which are not intended to come into contact with the human body or which are intended to come into contact with intact skin only.