Animal, Microbial and Recombinant Origin
Overview
Medical devices that contain or are made from non-viable animal tissues, animal derivatives, microbial substances, or recombinant materials are subject to specific regulatory requirements under Schedule 2 Rule 5.5 of the MD Regulations. These materials introduce additional risks, particularly around transmissible infectious agents (TSEs, viruses) and immune reactions.
Classification Under Rule 5.5
- Devices containing non-viable animal tissues or derivatives that are in contact with intact skin only → Class I (if the only reason for higher classification is this rule)
- Devices containing animal tissues or derivatives in contact with mucous membranes, compromised skin, or internal tissues → Class III
- Devices incorporating microbial or recombinant tissues, cells, or substances → Class III
Key Requirements
Source material control: Manufacturers must document the animal species and tissue type used, geographic sourcing, and health status of source animals. Suppliers must be audited and qualified.
Virus inactivation and TSE risk: Validated procedures for inactivating potential infectious agents — particularly transmissible spongiform encephalopathy (TSE) agents — must be in place where relevant.
Biocompatibility: Non-viable animal materials must be assessed for biocompatibility under EP 7 and ISO 10993.
Conformity assessment: Until July 2021, devices in this category required TGA conformity assessment certification. Since July 2021, EU notified body certificates under EU MDR are also accepted.