Skip to main content
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 23 June)

Government appoints Emma Jones CBE as new Small Business Commissioner to help tackle late payments Page summary: Government appoints new Small Business Commissioner as part of efforts to boost SMEs and tackle late payments Change made: First published. Time updated: 9:12am, 17 June 2025 Notice to exporters 2025/16: updated use of special and diacritic characters on the customs declaration service…
Ben Kemp
June 26, 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 23 June)

Untreated blood products for the manufacture of derived products for purposes outside the feed chain for farmed animals to, or transit through, the European Union and Northern Ireland: certificate 8308 updated Page summary: Apply online for an export health certificate (EHC) to export blood products from Great Britain (England, Scotland and Wales) to the EU or move them to Northern…
Ben Kemp
June 26, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

APHA – Border Trade Newsletter – getting it right at the border 19 06 25

Ongoing digital border service issue We are continuing to experience intermittent issues with the IPAFFS system. Please note this is not a CDS issue.  If you encounter any problems or disruptions, you must contact the STORM Incident Hub - manned 24/7. Please Email: Stormincidentresponse@defra.gov.uk Before contacting Storm, please ensure: The CHED is fully submitted and visible in IPAFFS. SPS checks (as…
Ben Kemp
June 26, 2025
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Airlock round 2 open until 14 July

Applications for the second round of the MHRA AI Airlock programme have opened following a successful pilot phase. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory ‘sandbox’ environment. Similar…
Ben Kemp
June 23, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New medical devices Post-market Surveillance regulations in force

New medical devices Post-market Surveillance regulations in force From today, new legal requirements for monitoring the safety of medical devices take effect, as part of our broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. Today’s reform applies to all UKCA- and…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Field safety notices: guidance for manufacturers

Field safety notices: guidance for manufacturers Page summary: How to write clear and effective field safety notices (FSNs) for medical devices. Change made: Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024. Time updated: 10:00am, 16 June 2025
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 16 June)

Borderline products: medical devices and other products Page summary: How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply. Change made: Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages. Time updated: 9:35am, 9 June 2025 Medical devices given…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 6 June)

NHS red tape blitz delivers game-changing new cancer treatment Page summary: Patients to benefit from new era in cancer treatment, as Government slashes red tape to unleash life-saving innovation Change made: First published. Time updated: 4:09pm, 10 June 2025 Our vision for a new model of NHS care Page summary: The Health and Social Care Secretary spoke at NHS ConfedExpo…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 16 June)

Supplying authorised medicines to Northern Ireland Page summary: What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Change made: • Added new overview section• Updated sections 2, 3 and 4 to reflect the implementation of the Windsor Framework on 1 January 2025 Time updated: 11:21am, 9 June 2025 Separation Agreement Joint Committee between the…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 16 June)

Employment Rights Bill: impact assessments Page summary: Impact assessments and analytical documents relating to the Employment Rights Bill. Change made: Number of small and micro business employees amended from 13 million to 9 million in ‘Employment Rights Bill economic analysis’ to mirror the figure used in the Summary Impact Assessment annex of the same document. Time updated: 3:13pm, 9 June…
Ben Kemp
June 18, 2025