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Guidance

Medical devices: list of UK approved bodies

Details of the organisations that are currently approved to undertake conformity assessments on medical devices.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
1 January 2021
Last updated:
17 July 2026
Show all updates

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

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

  3. Updated BSI Assurance UK ltd designation details.

  4. 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

  5. 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)

  6. 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

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

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

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

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

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

  12. Added new version of DEKRA Certification UK Ltd medical devices scope

  13. Updated 'DEKRA Certification UK Ltd medical devices scope '

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

  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.

  16. Updated 'DEKRA Certification UK Ltd medical devices scope'.

  17. Updated details for LNE-GMED UK Limited

  18. Added: LNE-GMED UK Limited in-vitro medical devices scope LNE-GMED UK Limited active implantable medical devices scope

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

  20. 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

  21. 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

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

  23. The three PDFs for BSI Assurance UK Ltd have been updated.

  24. A new entry (International (UK) Ltd Medical Devices Scope) has been added.

  25. Updated page to include TUV SUD BABT Active Implantable Medical Devices Scope

  26. Published - Intertek Medical Notified Body UK Ltd Medical Devices Scope

  27. Added 3 pdfs: AB_TUV RH_2571_Invitro_Diagnostic_Medical_Devices_Scope TUV Rheinland UK Limited Medical Devices Scope TUV SUD BABT Unlimited Medical Devices Scope

  28. The UL Internationa UK Ltd Scope document has been updated.

  29. Added DEKRA Certification UK Ltd (8505) to approved bodies

  30. 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.

  31. The contact person and email for SGS United Kingdom Ltd (0120) have been updated.

  32. Updated four attachments

  33. Changed designations for BSI Assurance UK Ltd under the MDR and IVDR and updated contact information.

  34. Added details of the designated scope for each approved body

  35. First published.

Documents

List of UK approved bodies for medical devices

HTML

BSI Assurance UK Ltd active implantable medical devices scope

PDF, 116 KB, 2 pages

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BSI Assurance UK Ltd in-vitro diagnostics medical devices scope

PDF, 141 KB, 3 pages

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BSI Assurance UK Ltd medical devices scope

PDF, 157 KB, 4 pages

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Eurofins E&E CML Limited medical devices scope

PDF, 101 KB, 4 pages

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Intertek Medical Notified Body UK Ltd medical devices scope

PDF, 235 KB, 6 pages

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Scarlet NB UK Ltd medical devices scope

PDF, 74 KB, 1 page

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SGS United Kingdom Limited in-vitro diagnostics medical devices scope

PDF, 103 KB, 2 pages

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SGS United Kingdom Limited medical devices scope

PDF, 158 KB, 7 pages

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Therapeutic Goods Administration (TGA) Medical Devices Scope

PDF, 136 KB, 3 pages

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TUV Rheinland UK limited in-vitro diagnostics medical devices scope

PDF, 143 KB, 4 pages

TUV Rheinland UK Limited medical devices scope

PDF, 221 KB, 8 pages

TUV SUD BABT active implantable medical devices scope

PDF, 79.3 KB, 2 pages

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TUV SUD BABT Unlimited In-Vitro Diagnostic Medical Devices Scope

PDF, 91.6 KB, 3 pages

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TUV SUD BABT Unlimited medical devices scope

PDF, 221 KB, 8 pages

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UL International (UK) Ltd in-vitro diagnostics medical devices scope

PDF, 98 KB, 4 pages

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UL International (UK) Ltd medical devices scope

PDF, 111 KB, 5 pages

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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.

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