Guidance

Medical devices: UK approved bodies

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

Documents

Scarlet NB UK Ltd Medical Devices Scope

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UL International (UK) Ltd Medical Devices Scope

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TUV SUD BABT Active Implantable Medical Devices Scope

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BSI Assurance UK Ltd Medical Devices Scope

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BSI Assurance UK Ltd Active Implantable Medical Devices Scope

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BSI Assurance UK Ltd In-vitro Diagnostics Medical Devices Scope

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DEKRA Certification UK Ltd Medical Devices Scope

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Intertek Medical Notified Body UK Ltd Medical Devices Scope

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LNE-GMED UK Limited Medical Devices Scope

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SGS United Kingdom Limited Medical Devices Scope

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SGS United Kingdom Limited In-vitro Diagnostics Medical Devices Scope

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TUV SUD BABT Unlimited Medical Devices Scope

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UL International (UK) Ltd In-vitro Diagnostics Medical Devices Scope

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Details

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

Published 1 January 2021
Last updated 1 March 2024 + show all updates
  1. 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

  2. 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

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

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

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

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

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

  8. 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

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

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

  11. 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.

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

  13. Updated four attachments

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

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

  16. First published.