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
162 MaySeptember 2022 — See all updates

Documents

UK approved bodies for medical devices

HTML

BSI Assurance UK Ltd Medical Devices Scope

PDF, 147 KB, 7 pages

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BSI Assurance UK Ltd Active Implantable Medical Devices Scope

PDF, 94.1 KB, 2 pages

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BSI Assurance UK Ltd In vitro Diagnostics Medical Devices Scope

PDF, 115 KB, 4 pages

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DEKRA Certification UK Ltd Medical Devices Scope

PDF, 105 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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UL International (UK) Ltd In-vitro Diagnostics Medical Devices Scope

PDF, 103 KB, 1 page

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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 162 MaySeptember 2022 + show all updates

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

  2. 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.

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

  4. Updated four attachments

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

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

  7. First published.