Devices Using Human/Animal Tissue
Overview
Devices incorporating non-viable human tissues or cells, or non-viable animal tissues or cells or their derivatives, are subject to specific requirements under MedDO Annex I Chapter II § 13. Depending on origin and use, these devices are classified as Class III (Rule 17 or 18).
Key Requirements
Animal-derived materials (Rule 17): Non-viable animal tissue and derivatives intended for exclusive external contact are Class I or IIa. All with intact skin or mucous membranes other animal tissue-based devices, and all devices with animal tissue in non-external contact, are Class III. TSE (transmissible spongiform encephalopathy) risk assessment is mandatory. Manufacturers must demonstrate TSE risk minimisation through sourcing, species selection, tissue type, and manufacturing processes.
Human-derived materials (Rule 18): Devices incorporating non-viable human tissues or cells (and their derivatives) are Class III. Procurement must comply with Swiss transplantation law and relevant EU tissue directives where applicable.
Swissmedic Blood and Tissue Authority
Swissmedic is the competent authority for blood, tissues, and cells under Swiss law (Transplantation Act and associated regulations). Devices incorporating human or animal tissues may be subject to dual oversight: device conformity assessment under MedDO and tissue/cell procurement and handling authorisation under Swiss transplantation law. Manufacturers should engage Swissmedic's tissue authority early to identify any parallel requirements.
Official Sources
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