Devices with human/animal tissues (Annex I §13)
MDR Annex VIII Rules 17–18 (classification); MDR Annex I §13 (GSPR); EN ISO 22442 series (animal tissue requirements); European Pharmacopoeia Chapter 5.2.8 (TSE risk minimisation). Devices made from non-viable human tissue are Class III; non-viable animal tissue devices are also Class III (with some Class IIb exceptions).