Finding a UK Approved Body
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
How to identify the right UK Approved Body for your device — using MHRA's designated list, understanding scope of designation, and selecting a UKAB for your device type.
MHRA's designated UKAB list
MHRA maintains a current list of designated UK Approved Bodies at: gov.uk/government/publications/approved-bodies-for-medical-devices
The list shows each UKAB's:
- Name and contact details
- Scope of designation — device types and conformity assessment procedures for which they are designated
- UKAB identification number (required on UKCA-marked devices assessed by that UKAB)
Scope of designation
Each UKAB is designated for specific device types and specific conformity assessment procedures. A UKAB may be designated to:
- Audit QMS for active implantable devices but not for IVDs
- Conduct type examinations for Class IIa devices but not for Class III
- Assess List A IVDs but not Class III general devices
Match your device type and required conformity assessment procedure to the UKAB's scope. A UKAB cannot assess a device outside its designated scope.
Current UK Approved Bodies
Key UKABs designated by MHRA include:
- BSI Group (British Standards Institution) — broad scope covering general devices, IVDs, AIMDs
- SGS UK Ltd — scope covering various device types
- Other designated bodies — check the current MHRA list as designations change
Selection considerations
| Factor | Guidance |
|---|---|
| Scope match | The UKAB must be designated for your device type and procedure |
| Capacity | UKABs have limited capacity — early engagement is essential, especially for 2030 UKCA deadline |
| Experience | Choose a UKAB with demonstrated experience in your specific device category |
| Timelines | Request indicative timelines at initial enquiry — these vary significantly |
| Cost | Obtain fee estimates as part of initial engagement |
Official references
| Reference | Description |
|---|---|
| MHRA: UK Approved Bodies | Current designated list |