Medical devices: list of UK approved bodies
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
Documents
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.
Updates to this page
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Updated to add HTML attachment for DEKRA Active Implantable Medical Devices Scope document
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Removed details for 'LNE-GMED UK' due to company ceasing UK operations.
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Eurofins E&E CML Limited added to the list of UK approved bodies.
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Amended to update details for DEKRA Certification UK Ltd (8505) in the page UK approved bodies for medical devices
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Added new version of DEKRA Certification UK Ltd medical devices scope
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Updated 'DEKRA Certification UK Ltd medical devices scope '
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Updated BSI Assurance UK Ltd medical devices scope and added DEKRA Certification UK Ltd in-vitro diagnostic medical devices scope.
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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.
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Updated 'DEKRA Certification UK Ltd medical devices scope'.
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Updated details for LNE-GMED UK Limited
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Added: LNE-GMED UK Limited in-vitro medical devices scope LNE-GMED UK Limited active implantable medical devices scope
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Pdf attachment has been replaced for Intertek Medical Notified Body UK Ltd
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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
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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
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Two new entries added to the page include: LNE-GMED UK Limited Medical Devices Scope and Scarlet NB UK Ltd Medical Devices Scope.
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The three PDFs for BSI Assurance UK Ltd have been updated.
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A new entry (International (UK) Ltd Medical Devices Scope) has been added.
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Updated page to include TUV SUD BABT Active Implantable Medical Devices Scope
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Published - Intertek Medical Notified Body UK Ltd Medical Devices Scope
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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
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The UL Internationa UK Ltd Scope document has been updated.
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Added DEKRA Certification UK Ltd (8505) to approved bodies
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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.
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The contact person and email for SGS United Kingdom Ltd (0120) have been updated.
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Updated four attachments
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Changed designations for BSI Assurance UK Ltd under the MDR and IVDR and updated contact information.
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Added details of the designated scope for each approved body
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First published.