UK approved bodies for medical device conformity assessment

This information provides details of the bodies that have been approved under the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for the assessment of medical devices required by the regulations.

Updated document to reflect latest approved bodies services and added one new designation scope

MDS 7009 has been added to Intertek’s medical devices scope.

Updated BSI Assurance UK ltd designation details.

Updated to add the 2026 versions of: BSI Assurance UK Ltd in-vitro diagnostics medical devices scope, BSI Assurance UK Ltd active implantable medical devices scope, BSI Assurance UK Ltd medical devices scope

Updated entry for TUV SUD BABT Unlimited (0168) to include:

- In-Vitro Diagnostic Medical Devices (designation expires on 2 July 2030)

- Under Part IV of the Medical Devices Regulation as they apply in Great Britain (SI 2002 NO 618, as amended) (UK MDR 2002)

Added Active Implantable Medical Devices to DEKRA certification UK Ltd to approved list of medical devices for which the approved body is permitted to issue UKCA certification

Added DEKRA Active Implantable Medical Devices Scope May25 to Medical devices: list of UK approved bodies

Updated to add HTML attachment for DEKRA Active Implantable Medical Devices Scope document

Removed details for 'LNE-GMED UK' due to company ceasing UK operations.

Eurofins E&E CML Limited added to the list of UK approved bodies.

Amended to update details for DEKRA Certification UK Ltd (8505) in the page UK approved bodies for medical devices

Added new version of DEKRA Certification UK Ltd medical devices scope

Updated 'DEKRA Certification UK Ltd medical devices scope '

Updated BSI Assurance UK Ltd medical devices scope and added DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope.

From the document titled, ‘UL International (UK) medical devices scope’, there was the removal of 4 codes from the UK Approved Body’s designation scope, including MD 0105 - Non-active ophthalmologic devices, MD 1105 - Active ophthalmologic devices, MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART) and MD 1112 - Medical gas supply systems and parts thereof.

Updated 'DEKRA Certification UK Ltd medical devices scope'.

Updated details for LNE-GMED UK Limited

LNE-GMED UK Limited in-vitro medical devices scope

LNE-GMED UK Limited active implantable medical devices scope

Pdf attachment has been replaced for Intertek Medical Notified Body UK Ltd

The following PDFs have been updated:

BSI Assurance UK Ltd Medical Devices Scope

BSI Assurance UK Ltd Active Implantable Medical Devices Scope

BSI Assurance UK Ltd In-vitro Diagnostics Medical Devices Scope

Updated the details for LNE-GMED UK Limited, TUV SUD BABT Unlimited (0168) and Scarlet NB UK Ltd (8536) in the 'UK approved bodies for medical devices' guidance page

Two new entries added to the page include: LNE-GMED UK Limited Medical Devices Scope and Scarlet NB UK Ltd Medical Devices Scope.