UK Approved Bodies for medical devices
Designated UK Approved Bodies authorised to conduct conformity assessments for medical devices under UK MDR 2002.
- Total UK Approved Bodies designated
- 9
- BSI Assurance UK Ltd (0086)
- Parts II, III, and IV (general medical devices, active implantable devices, IVDs) — broadest scope
- SGS United Kingdom Ltd (0120)
- Part II (general medical devices)
- UL International (UK) Ltd (0843)
- Parts II and IV (general medical devices, IVDs)
- DEKRA Certification UK Ltd
- Parts II, III, and IV (general medical devices, active implantable devices, IVDs)
- TUV SUD BABT
- Parts II, III, and IV (general medical devices, active implantable devices, IVDs)
- Intertek Medical Notified Body UK Ltd
- Part II (general medical devices)
- TUV Rheinland UK Ltd
- Parts II and IV (general medical devices, IVDs)
- Eurofins E&E CML Limited
- Part II (general medical devices)
- Scarlet NB UK Ltd
- Part II (general medical devices)
- Part II scope
- General medical devices (MDD)
- Part III scope
- Active implantable medical devices (AIMDD)
- Part IV scope
- In vitro diagnostic medical devices (IVDD)
- How to select an Approved Body
- Based on device class, intended use, and the body's scope of designation