Human Tissue Devices
MDR Reference: Annex I, GSPR 13.2; Annex II, Section 6.2.2
BPG Rev.4 Reference: Section 6.2.2
Service Item ID: mdr_sec06_human_tissue
Applicability: Devices incorporating substances derived from human tissues or cells
Overview
Devices manufactured using human-origin tissues, cells, or substances (e.g., demineralised bone matrix, human-derived collagen) must address specific risks including TSE/CJD transmission and comply with donor selection, traceability, and processing validation requirements.
Key Requirements
- TSE/CJD risk assessment: Evaluate prion transmission risk
- Donor selection criteria: Screening and eligibility criteria per applicable tissue banking directives
- Source traceability: End-to-end traceability from donor to finished device
- Virus/agent inactivation: Processing validation for pathogen clearance
- Ethical sourcing: Informed consent, compliance with Directive 2004/23/EC (tissues and cells)
Key Deliverables
| Document | Description |
|---|---|
| TSE/CJD Risk Assessment | Risk analysis for prion transmission |
| Donor Selection & Screening | Criteria and testing for donor eligibility |
| Source Traceability Documentation | Full chain of custody from donor to device |
| Processing Validation | Virus/agent inactivation studies |
| Ethical Compliance | Consent documentation, regulatory approvals |
GSPR Mapping
| GSPR | Requirement |
|---|---|
| 13.2 | Devices incorporating human tissues: source traceability, virus inactivation |
Related Topics
- Animal Tissue Devices -- Analogous requirements for animal-origin tissues
- Biocompatibility -- Post-processing biological evaluation