Human tissue & cells components
Devices incorporating non-viable human tissue or cells are addressed in Schedule 2, Rule 8 (Classification) and Schedule 1 (Essential Requirements) of the UK MDR 2002. The Human Tissue Authority (HTA) regulates activities involving human tissue under the Human Tissue Act 2004 (England, Wales, and Northern Ireland) and the Human Tissue (Scotland) Act 2006. Both MHRA and HTA oversight may apply simultaneously.
The regulatory landscape for human tissue in medical devices
Products incorporating human tissue or cells sit at a complex regulatory intersection:
| Product type | Primary regulator | Framework |
|---|---|---|
| Device incorporating non-viable human tissue/cells (device is principal) | MHRA | UK MDR 2002 |
| Tissue/cell transplant or therapy (tissue/cells are principal) | HTA + MHRA | Human Tissue Act + Human Medicines Regulations |
| Advanced therapy medicinal products (ATMPs) — gene/cell therapies | MHRA (medicines) | Human Medicines Regulations 2012 |
| Research involving human tissue | HTA | Human Tissue Act 2004 |
The principal mode of action determines which framework leads.
Devices incorporating non-viable human tissue — UK MDR 2002
A device that incorporates non-viable (non-living) human tissue or cells — where the tissue's function is ancillary to the device's principal mechanical, physical, or structural function — is regulated as a medical device.
Classification: Classification depends on the device type:
- Under Rule 8 (long-term surgical implants): typically Class III if the human tissue is incorporated as an integral part of an implant
- The inclusion of human tissue generally elevates risk classification
Essential Requirements: Human tissue in a device must be assessed for:
- Biocompatibility and immunogenicity
- Disease transmission risk (donor screening and testing requirements)
- Sterilisation or viral inactivation process validation
- Traceability from donor to recipient
HTA involvement: Even where MHRA regulates the device, activities involving the procurement, processing, storage, or use of human tissue are subject to HTA licensing requirements. Manufacturers working with human tissue must hold appropriate HTA licences.
Examples:
- Demineralised bone matrix (DBM) products used as bone graft substitutes — Class III device incorporating processed human bone
- Processed human dermis for wound repair — Class III device
- Human serum albumin-coated catheters — device incorporating human plasma protein
What is not a medical device
- Solid organ transplants (kidney, liver, heart) — not medical devices; regulated under HTA/transplant law
- Blood transfusion components — regulated separately (blood components, not medical devices)
- ATMPs (gene therapy, somatic cell therapy, tissue engineering products where cells are the principal therapeutic agent) — regulated as medicines by MHRA
Traceability requirements
Products incorporating human tissue must maintain donor-to-recipient traceability:
- Donor identification (coded, not personally identifiable to the patient)
- Batch/lot number linking to specific donors
- Recipient healthcare facility and patient records (held by the facility)
This traceability is required to enable rapid notification and investigation in the event of a donor-linked disease transmission event.
Related pages
- Classification rules — Rule 8 and Rule 17
- Devices incorporating a medicinal substance
- Borderline & combination products
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Schedule 2, Rule 8 | Classification of implants incorporating human tissue |
| Human Tissue Act 2004 | HTA regulatory framework (England, Wales, NI) |
| HTA: Guidance for establishments | HTA licensing requirements |
| MHRA: Advanced therapy medicinal products | ATMP regulatory guidance |
| EU MDR 2017/745, Art. 1(6) | EU treatment of devices incorporating human tissue (NI reference) |