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Approved bodies under Medical Devices Regulations 2002?(SI 2002 No 618, as amended) (UK MDR 2002) for medical devices.
From the document titled, UL International (UK) medical devices scope, there was the removal of 4 codes from the UK Approved Bodys 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.
Updated 'DEKRA Certification UK Ltd medical devices scope'.
Updated details for LNE-GMED UK Limited
Added:LNE-GMED UK Limited in-vitro medical devices scopeLNE-GMED UK Limited active implantable medical devices scope
Pdf attachment has been replaced for Intertek Medical Notified Body UK Ltd
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
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
Two new entries added to the page include: LNE-GMED UK Limited Medical Devices Scope and Scarlet NB UK Ltd Medical Devices Scope.
The three PDFs for BSI Assurance UK Ltd have been updated.
A new entry (International (UK) Ltd Medical Devices Scope) has been added.
Updated page to include TUV SUD BABT Active Implantable Medical Devices Scope
Published - Intertek Medical Notified Body UK Ltd Medical Devices Scope
Added 3 pdfs:AB_TUV RH_2571_Invitro_Diagnostic_Medical_Devices_ScopeTUV Rheinland UK Limited Medical Devices ScopeTUV SUD BABT Unlimited Medical Devices Scope
The UL Internationa UK Ltd Scope document has been updated.
Added DEKRA Certification UK Ltd (8505) to approved bodies
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.
The contact person and email for SGS United Kingdom Ltd (0120) have been updated.
Updated four attachments
Changed designations for BSI Assurance UK Ltd under the MDR and IVDR and updated contact information.
Added details of the designated scope for each approved body
First published.