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Guidance: Medical devices: UK approved bodies

Medicines Healthcare Products Regulatory Agency

April 23
14:43 2024

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 23 April 2024 +show all updates
  1. Added:LNE-GMED UK Limited in-vitro medical devices scopeLNE-GMED UK Limited active implantable medical devices scope

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

  3. 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

  4. 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

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

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

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

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

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

  10. Added 3 pdfs:AB_TUV RH_2571_Invitro_Diagnostic_Medical_Devices_ScopeTUV Rheinland UK Limited Medical Devices ScopeTUV SUD BABT Unlimited Medical Devices Scope

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

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

  13. The SGS United Kingdom Limited Medical Devices Scope document has been updated to reflect the removal of code MD 0110 from Approved Bodys 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 Bodys designated scope.

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

  15. Updated four attachments

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

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

  18. First published.

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