French Public Health Code
In forceMedical devices and active implantable medical devices manufactured from non-viable tissues of animal origin or non-viable products derived from tissues of animal origin, falling within the scope defined in paragraphs 2 and 4 of Article 1 of Commission Regulation (EU) No 722/2012 of 8 August 2012 on specific requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC for active implantable medical devices and medical devices manufactured utilising tissues of animal origin, may not be placed on the market or put into service unless they comply with the specific requirements laid down in that Regulation.
Collagen, gelatine and tallow used in the manufacture of medical devices shall meet at least the conditions necessary to be considered fit for human consumption, which are laid down in Regulation (EC) No 1069/2009.
The animal tissues or their derived products referred to in the first paragraph of this article are derived from bovine, ovine and caprine species, as well as from deer, elk, mink and cats. These tissues or their derived products are intended to be disposed of during the manufacturing stages of the medical device or to be incorporated permanently into it.
Tissues or derived products classified as presenting a high risk of infection with transmissible spongiform encephalopathies (TSEs) may not be used in the manufacture of medical devices, unless their use is made necessary, in exceptional circumstances, in the absence of any replacement tissue, by the importance of the expected benefit for the patient. The classification of the infectivity of derived tissues or products with regard to the risk of transmission of transmissible spongiform encephalopathies is established in accordance with point 1.2.3 of Annex I to Regulation (EU) No 722/2012 referred to above.
