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Regulatory Affairs Newsletter Archive

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The Medical Devices (Amendment) (Great Britain) Regulations 2025

Baroness Merron and her team have successfully steered through The Medical Devices (Amendment) (Great Britain) Regulations 2025. This addresses the four pieces of EU legislation that supported the UK MDR 2002, which were due to sunset on 25th and 26th May 2025. This allows business as usual until the MHRA and DHSC can incorporate future updates into future UK, to align…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA – New MORE Guidance on implementing the changing data requirements for medical device reporting

We have published new guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain. The new implementation guide for our Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025. Please…
Ben Kemp
May 23, 2025
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UK Research and Innovation Weekly Digest Bulletin

Simple test could better predict risk of heart disease Researchers have shown that a combination of two lipoprotein markers, measured in a simple blood test, can give more accurate information about individual risk of heart disease than the current blood cholesterol test.   Where we live affects our health and how we age Research is showing how environmental factors such…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 19 May)

Medical devices: post-market surveillance Page summary: Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Updated to provide the latest information regarding the MORE portal. Time updated: 12:08pm, 16 May 2025 Manufacturer’s Online Reporting Environment (MORE) Page summary: A a digital platform designed to facilitate the reporting,…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 19 May)

Foot and Mouth disease controls eased for Germany Page summary: Personal imports for travellers from the EU remain banned Change made: First published. Time updated: 4:51pm, 14 May 2025 Foot and mouth disease: latest situation Page summary: Current cases of foot and mouth disease, trade restrictions and risk level. Change made: The restrictions on commercially importing from Germany have been…
Ben Kemp
May 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero Updates (WC 19 May)

Taking part in the UK Emissions Trading Scheme markets Page summary: This guidance explains the operation of the UK ETS markets and how to take part in auctions and in trading on the secondary market. Change made: Cost Containment Mechanism figures updated for latest month. Time updated: 5:15pm, 12 May 2025 Participating in the UK Emissions Trading Scheme (UK ETS)…
Ben Kemp
May 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT Updates (WC 19 May)

Cyber security in enterprise connected devices Page summary: This page details the government’s work to improve the cyber security of enterprise connected devices (or ‘IoT’ devices.) Change made: First published. Time updated: 12:01am, 12 May 2025 Research on cyber security in enterprise connected devices Page summary: This research sets out security vulnerabilities in a range of connected devices commonly-used by…
Ben Kemp
May 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Updates (WC 19 May)

Draft strategic steer to the Competition and Markets Authority Page summary: This steer sets out government priorities for the Competition and Markets Authority (CMA). Change made: Consultation response added. Time updated: 12:01am, 15 May 2025 Competition watchdog gets green light for growth in latest move to back business Page summary: Businesses and consumers will benefit from new growth-focused Strategic Steer…
Ben Kemp
May 22, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Update from GOV.UK for: Medical devices: post-market surveillance

Medical devices: post-market surveillance Page summary: Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Updated to provide the latest information regarding the MORE portal. Time updated: 12:08pm, 16 May 2025
Ben Kemp
May 22, 2025
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