Guidance

Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

From:
Medicines and Healthcare products Regulatory Agency
Published
1 January 2021
Last updated
214 JulyNovember 2024 — See all updates

Documents

UK approved bodies for medical devices

HTML

Scarlet NB UK Ltd medical devices scope

PDF, 74 KB, 1 page

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UL International (UK) Ltd medical devices scope

PDF, 115111 KB, 5 pages

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TUV SUD BABT active implantable medical devices scope

PDF, 79.3 KB, 2 pages

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BSI Assurance UK Ltd medical devices scope

PDF, 133 KB, 7 pages

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BSI Assurance UK Ltd active implantable medical devices scope

PDF, 82.6 KB, 2 pages

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BSI Assurance UK Ltd in-vitro diagnostics medical devices scope

PDF, 102 KB, 4 pages

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DEKRA Certification UK Ltd medical devices scope

PDF, 104 KB, 3 pages

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Intertek Medical Notified Body UK Ltd medical devices scope

PDF, 214 KB, 7 pages

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LNE-GMED UK Limited active implantable medical devices scope

PDF, 81.9 KB, 2 pages

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LNE-GMED UK Limited medical devices scope

PDF, 120 KB, 5 pages

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LNE-GMED UK Limited in-vitro medical devices scope

PDF, 94.8 KB, 3 pages

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SGS United Kingdom Limited medical devices scope

PDF, 158 KB, 7 pages

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SGS United Kingdom Limited in-vitro diagnostics medical devices scope

PDF, 103 KB, 2 pages

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TUV Rheinland UK Limited medical devices scope

PDF, 221 KB, 8 pages

TUV Rheinland UK limited in-vitro diagnostics medical devices scope

PDF, 143 KB, 4 pages

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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Details

Approved bodies under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) for medical devices.

Updates to this page

Published 1 January 2021
Last updated 214 JulyNovember 2024 + show all updates

  1. 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.

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

  3. Updated details for LNE-GMED UK Limited

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

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

  6. 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

  7. 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

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

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

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

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

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

  13. 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

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

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

  16. 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.

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

  18. Updated four attachments

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

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

  21. First published.

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