Medical devices: list of UK approved bodies
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Documents
Details
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.
Updates to this page
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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)
Update history
2025-12-18 16:33
Updated BSI Assurance UK ltd designation details.
2025-12-15 15:20
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
2025-07-04 12:37
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)
2025-05-23 19:10
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
2025-05-23 19:06
Added DEKRA Active Implantable Medical Devices Scope May25 to Medical devices: list of UK approved bodies
2025-05-06 17:00
Updated to add HTML attachment for DEKRA Active Implantable Medical Devices Scope document
2025-05-06 09:45
Removed details for ‘LNE-GMED UK’ due to company ceasing UK operations.
2025-04-25 09:50
Eurofins E&E CML Limited added to the list of UK approved bodies.
2025-02-19 13:20
Amended to update details for DEKRA Certification UK Ltd (8505) in the page UK approved bodies for medical devices
2025-02-18 17:40
Added new version of DEKRA Certification UK Ltd medical devices scope
2025-01-21 11:23
Updated ‘DEKRA Certification UK Ltd medical devices scope ‘
2025-01-08 16:33
Updated BSI Assurance UK Ltd medical devices scope and added DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope.
2024-11-14 11:15
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.
2024-07-02 10:51
Updated ‘DEKRA Certification UK Ltd medical devices scope’.
2024-05-02 15:09
Updated details for LNE-GMED UK Limited
2024-04-23 15:43
Added:LNE-GMED UK Limited in-vitro medical devices scopeLNE-GMED UK Limited active implantable medical devices scope
2024-03-25 16:10
Pdf attachment has been replaced for Intertek Medical Notified Body UK Ltd
2024-03-01 15:54
The following PDFs have been updated:BSI Assurance UK Ltd Medical Devices ScopeBSI Assurance UK Ltd Active Implantable Medical Devices ScopeBSI Assurance UK Ltd In-vitro Diagnostics Medical Devices Scope
2024-01-30 15:34
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
2024-01-29 12:35
Two new entries added to the page include: LNE-GMED UK Limited Medical Devices Scope and Scarlet NB UK Ltd Medical Devices Scope.
2024-01-24 16:22
The three PDFs for BSI Assurance UK Ltd have been updated.
2024-01-23 15:27
A new entry (International (UK) Ltd Medical Devices Scope) has been added.
2024-01-16 17:14
Updated page to include TUV SUD BABT Active Implantable Medical Devices Scope
2023-08-24 09:05
Published – Intertek Medical Notified Body UK Ltd Medical Devices Scope
2023-08-11 14:18
Added 3 pdfs:ABTUV RH2571InvitroDiagnosticMedicalDevices_ScopeTUV Rheinland UK Limited Medical Devices ScopeTUV SUD BABT Unlimited Medical Devices Scope
2022-12-20 12:27
The UL Internationa UK Ltd Scope document has been updated.
2022-09-02 11:14
Added DEKRA Certification UK Ltd (8505) to approved bodies
2022-05-16 19:14
The SGS United Kingdom Limited Medical Devices Scope document has been updated to reflect the removal of code MD 0110 from Approved Body’s designated scope. The UL International (UK) Ltd In-vitro Diagnostics Medical Devices Scope document has been updated to reflect the removal of Annex VII from Approved Body’s designated scope.
2022-03-02 15:19
The contact person and email for SGS United Kingdom Ltd (0120) have been updated.