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 others 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 also serves as the competent authority for blood, tissues, and cells under Swiss law. There may be parallel authorisation requirements for the tissue/cell component in addition to the device registration.
Official Sources
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