What are UK Approved Bodies?
See the official sources listed in the references table at the bottom of this page.
This site provides general information only and does not constitute legal or regulatory advice.
Overview
UK Approved Bodies (UKABs) are the UK equivalent of EU Notified Bodies — organisations designated by MHRA to carry out third-party conformity assessment of medical devices for the GB market.
Definition
A UK Approved Body (UKAB) is an organisation formally designated by MHRA to assess whether medical devices conform to the requirements of UK MDR 2002 before they bear the UKCA mark. UKABs carry out the third-party conformity assessment required for Class IIa, IIb, III, AIMD, and higher-risk IVD devices.
UKABs are the UK equivalent of EU Notified Bodies — but UKAB certificates are valid only for the GB market, not for the EU or Northern Ireland market.
What UKABs do
- Audit manufacturers' Quality Management Systems (QMS)
- Review technical files and design dossiers
- Issue certificates (QMS certificates, Design Examination Certificates, Type Examination Certificates)
- Conduct periodic surveillance audits and unannounced audits
- Notify MHRA of certificate suspensions and withdrawals
How UKABs differ from EU Notified Bodies
| Aspect | UK Approved Body | EU Notified Body |
|---|---|---|
| Designated by | MHRA | European Commission (via national CA) |
| Valid for | GB market only | EU market + Northern Ireland |
| List maintained by | MHRA | NANDO database |
| Oversight | MHRA | National CA + EC peer review |
| Number currently designated | Small (see MHRA list) | 40+ for MDR/IVDR |
Official references
| Reference | Description |
|---|---|
| MHRA: UK Approved Bodies list | Current list of designated UKABs |
| UK MDR 2002, Schedule 3 | Conformity assessment procedures — UKAB role |