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CEN adopts ISO 17043 as European standard

CEN have formally adopted ISO 17043: Conformity assessment — General requirements for proficiency testing as a European standard. This may impact EQA providers providing proficiency testing services such as end user POCT schemes for staff proficiency.
Ashleigh
May 26, 2023
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Coronavirus Test Device Approvals Transition

The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May. The MHRA have provided the following information: The UK Coronavirus Test Device Approvals regulatory regime is one of the most…
Ashleigh
May 12, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 01 May)

Please note this is an extract of the original bulletin.   The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: The date of when the survey will…
Ashleigh
May 12, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 May)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…
Ashleigh
May 12, 2023