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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
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 May)

Please note this is an extract of the original bulletin. COVID-19 test approval: how to apply Page summary: How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Change made: Updated notice on change to the application process. Global AI challenge to investigate veterans’ cardiovascular health launched Page summary: A brand-new challenge…
Tehelj
May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Submitting Adverse Incidents to Medical Devices to the MHRA – enhancements to the MORE portal

Adverse incidents involving medical devices which occur in the UK are reported to the MHRA via the MORE portal. The MHRA is in the process of implementing several changes to make the MORE portal automatized and easier to use. These updates are expected from June onwards. The MHRA have provided the following information: In our last update, we said that…
Tehelj
May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 May)

Please note this is an extract of the original bulletin. Six new community diagnostic centres to deliver more than 500,000 lifesaving checks a year Page summary: New CDCs to open in regions across the UK, adding to the 106 centres already up and running and helping to cut NHS waiting lists Change made: First published. Health secretary attends Japan summit…
Tehelj
May 26, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 May)

Please note this is an extract of the original bulletin. UK and Japan strengthen science and tech ties in Tokyo Page summary: UK and Japan today signed a renewed science and technology deal, building on decades of close cooperation. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects…
Tehelj
May 26, 2023
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