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Regulatory Affairs Newsletter

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ISO TC 210 Working group

Dear members, following on from the good news that ISO TC 210 WG had reconfirmed ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, meaning that it remains unchanged until April 2030, two other updates have been received. The guidance on the implementation of ISO 13485 will be updated and released as ISO TS 23485 in…
Ben Kemp
November 6, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Reminder – Moving to a single list for UK sanctions designations

Reminder - Moving to a single list for UK sanctions designations - 28 January 2026 The OFSI Consolidated List of Asset Freeze Targets is closing. From 09:00 GMT on Wednesday 28 January 2026 the UK Sanctions List will be the only source for all UK sanctions designations. There will be no changes to the structure of the current UK Sanctions List. Guidance has been published…
Ben Kemp
November 6, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

Abiraterone recommendation could save NHS millions

The NHS has published final draft guidance recommending abiraterone and its generic variants in combination with androgen deprivation therapy and prednisolone or prednisone as an option for adults with newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer. The decision marks a significant shift from our 2021 guidance, which could not recommend abiraterone because, at the time, it did not represent value…
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 3rd Nov)

Expressions of Interest for Northern Ireland Business Stakeholders Group Page summary: Expressions of Interest for the Northern Ireland Business Stakeholders Group on the Windsor Framework Change made: Updated the deadline for receipt of applications Time updated: 11:35am, 27 October 2025 Special Directions made under section 30 of the Customs and Excise Management Act 1979 Page summary: Special Directions made under…
Ben Kemp
November 6, 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 3rd Nov)

Carbon budget and growth delivery plan, 2025 Page summary: The Carbon Budget and Growth Delivery Plan sets out how the government meets its statutory carbon budgets and secure the benefits of this transition for people and businesses. Change made: First published. Time updated: 3:19pm, 29 October 2025 UK net zero transition: investment opportunities Page summary: This investor prospectus outlines where…
Ben Kemp
November 6, 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 3rd Nov)

Temporary agreement between the Swiss Confederation (Switzerland) and the UK on services mobility Page summary: Temporary agreement documents and the exchanges of notes extending the agreement. Change made: ‘October 2025: Exchange of notes between the UK and Switzerland on extending the temporary Services Mobility Agreement’ added in PDF and web versions. Time updated: 9:28am, 28 October 2025 UK-Switzerland Services Mobility…
Ben Kemp
November 6, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Updates (WC 3rd Nov)

AI Growth Lab Page summary: We are seeking views on the AI Growth Lab, a cross-economy sandbox in the UK to help inform government policy development. Change made: Questions 23, 25 and 27 updated. They were published incorrectly on 21 October 2025 in the HTML and PDF version of AI Growth Lab. Time updated: 2:03pm, 29 October 2025 DSIT research…
Ben Kemp
November 6, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

ISO 13485:2016 reconfirmed

Please be advised that ISO TC210 have reconfirmed ISO13485:2016 until 2030. Note that ISO 9000 QMS – fundamentals and vocabulary will be updated to ISO9000:2026 and this will have a impact on ISO13485 as a normative reference, but the core requirements of ISO 13485:2016 will remain.
Ben Kemp
October 31, 2025
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU UDI and UDI EUDAMED module updates

📌 On 29 October 2025, a new meeting of the Subgroup on Unique Device Identification (UDI, WG 9) of the Medical Device Coordination Group (MDCG) takes place, in its sessions for Competent Authorities only, and with the Stakeholders also. 👉 The draft Agendas, working documents and subsequent minutes are going to be made publicly available on the "Register of Commission…
Ben Kemp
October 31, 2025
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