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Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Animal and Plant Health Agency Updates (WC 26th May)

Single case of atypical BSE confirmed on a farm in Essex Page summary: A single case of atypical Bovine Spongiform Encephalopathy (BSE) has been confirmed on a farm in Essex, the Animal and Plant Health Agency (APHA) confirmed today (Tuesday 20 May). Change made: First published. Time updated: 10:37am, 20 May 2025 Export other mammals to Northern Ireland: certificate 9110 updated…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Policy papers and consultations with organisations of Animal and Plant Health Agency, Department for Environment, Food & Rural Affairs, Medicines and Healthcare products Regulatory Agency, and Office for Product Safety

Government response to OEP review: implementation of the duty to have due regard to the Environmental Principles Policy Statement Page summary: The government’s response to the Office for Environmental Protection review of the duty to have due regard to the Environmental Principles Policy Statement. Change made: First published. Time updated: 10:45am, 19 May 2025 MHRA draft guideline on the use…
Ben Kemp
May 28, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

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
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