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Regulatory Affairs Newsletter

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
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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
MedTech Europe Updates Regulatory Affairs NewsletterMedTech Europe Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU MIR 7.3.1 update

The European Commission is planning another MIR 7.3.1 form update to make signature optional (as well as improvements in other remaining issues) which should be published soon somewhere in November. They have also extended the transition timeline for the mandatory implementation of the MIR 7.3.1 form for 4 months after the latest update (counting from the latest update to be…
Ben Kemp
October 31, 2025
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

The Registrar of Companies (Fees) (Amendment) Regulations 2025

The Registrar of Companies (Fees) (Amendment) Regulations 2025 These Regulations amend the Registrar of Companies (Fees) (Companies, Overseas Companies and Limited Liability Partnerships) Regulations 2012 (S.I. 2012/1907) (“the 2012 Regulations”), the Registrar of Companies (Fees) (Registrar of Overseas Entities) Regulations 2024 (“the 2024 Regulations”), the Registrar of Companies (Fees) (Limited Partnerships and Newspaper Proprietors) Regulations 2009 (S.I. 2009/2392) (“the 2009…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Border Trade Newsletter – getting it right at the border 30 10 25

Getting it right at the border  This newsletter covers the latest operational updates on requirements and border controls for importing live animals, germinal products, products of animal origin and animal by-products into Great Britain. In this newsletter: Sevington Key Reminders for Trade Join the APHA Business Readiness Forum Lumpy skin disease: import of germinal products from France, Italy and Spain…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Important changes to Supplementary Protection Certificates

Important changes to Supplementary Protection Certificates We are publishing weekly blog posts to help you prepare for the arrival of our One IPO Patent Service. Each post covers a different aspect of the new digital platform helping to ensure that you are ready for the changes This week we are looking at Supplementary Protection Certificates (SPCs). From spring 2026, you'll…
Ben Kemp
October 31, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming EU active substance approval and expiry date, and expiry dates postponed

Upcoming EU active substance approval date Apply for product authorisation by the deadline to keep your products on the NI market The following EU Biocidal Products Regulation (EU BPR) active substance approval date is coming up: 1 October 2026 1,2-benzisothiazol-3(2H)-one (BIT) (CAS 2634-33-5 EC 220-120-9) in product types 6 and 13 formic acid (CAS 64-18-6 EC 200-579-1) in product type…
Ben Kemp
October 31, 2025
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