Animal Tissue Devices
MDR Reference: Annex II, Section 6.2.3; Regulation (EU) 722/2012
BPG Rev.4 Reference: Section 6.2.3
Service Item ID: mdr_sec06_animal_tissue
Applicability: Devices utilising tissues or derivatives of animal origin
Overview
Medical devices incorporating animal-origin tissues (e.g., bovine pericardium, porcine collagen) must comply with Regulation (EU) 722/2012 and the ISO 22442 series. The primary concern is TSE (transmissible spongiform encephalopathy) risk management.
Key Standards
| Standard | Title |
|---|---|
| ISO 22442-1:2020 | Animal tissues and their derivatives -- Part 1: Application of risk management |
| ISO 22442-2:2020 | Part 2: Controls on sourcing, collection and handling |
| ISO 22442-3:2020 | Part 3: Validation of the elimination and/or inactivation of viruses and TSE agents |
| Reg (EU) 722/2012 | Particular requirements for devices manufactured using animal tissues |
Key Deliverables
| Document | Description |
|---|---|
| TSE Risk Assessment | Species, geographic origin, tissue type, risk classification |
| Sourcing & Traceability | Supplier qualification, batch traceability, veterinary certificates |
| Virus Inactivation Validation | Log reduction studies for relevant viral families |
| TSE Agent Inactivation | Process validation for prion clearance |
| Biocompatibility of Processed Tissue | Post-processing biological evaluation |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 13.1 | Devices incorporating animal tissues: TSE risk management |
| 11.1 | Material safety |
Related Topics
- Biocompatibility -- Biological evaluation of processed tissue
- Human Tissue Devices -- Analogous requirements for human-origin tissues