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Regulatory Affairs Newsletter

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CELEX:32025R2645: Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance)

Dear members, for your information. New EU legislation that allows the ability for compulsory licensing of Intellectual property during a crisis. Regulation (EU) 2025/2645 of the European Parliament and of the Council of 16 December 2025 on compulsory licensing for crisis management and amending Regulation (EC) No 816/2006 (Text with EEA relevance) View article...
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

EU IVDR MDCG 2025-10 – Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices

Dear members, please see new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices MDCG 2025-10. The guidance was developed in co-operation with the MedTech Europe PMS and Vigilance Working group. The European Commission has recently published a new Guidance Document on post-market surveillance of medical devices and in vitro diagnostic medical devices (MDCG 2025–10).…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UK Health Security Agency Update (WC 5th January)

GP out-of-hours syndromic surveillance: weekly bulletins for 2025 Page summary: The number of people contacting their GPs outside of surgery hours under the syndromic surveillance system. Change made: Added week 52 bulletin. Time updated: 9:00am, 2 January 2026 National ambulance syndromic surveillance: weekly bulletins 2025 Page summary: The number of people calling ambulances each day, with results published every week…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 18th Dec)

Open general export licence (export of dual-use items to EU member states) Page summary: Licence for the export of of dual-use items to EU member states. Change made: This open general export licence (OGEL) has been updated to reflect changes to the list of controlled items in the Export Control Order 2008 and the assimilated Dual-Use Regulation (EC) No 428/2009.…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 18th Dec)

Radio equipment regulations Page summary: Guidance for businesses on the Radio Equipment Regulations 2017 and Radio Equipment (Amendment) (Northern Ireland) Regulations 2024 and 2025. Change made: New guide added on the Radio Equipment (Amendment) (Northern Ireland) Regulations 2025, with related updates to the NI guide. Time updated: 12:05am, 16 December 2025 My safety: smart connected products Page summary: OPSS is…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Energy Security and Net Zero Update (WC 18th Dec)

UK Emissions Trading Scheme and Carbon Price Support: apply for compensation Page summary: How to apply for compensation for the indirect costs of the UK Emissions Trading Scheme (UK ETS) and the Carbon Price Support (CPS) mechanism. Change made: Annual update made to ‘Data for UK ETS and CPS eligibility and compensation calculation form (B03 and B04 forms)’ to allow…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Update (WC 18th December)

Men's Health Strategy for England Page summary: Details the government’s 10-year vision for men’s health and the actions we are taking now to improve the health and wellbeing of all men and boys in England. Change made: Updated to include a revised PDF of ‘Men’s health: a strategic vision for England’, with a correction note explaining the changes since first…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Science, Innovation and Technology Update (WC 18th Dec)

The third UK-EU Cyber Dialogue took place in Brussels Page summary: The third UK-EU Cyber Dialogue took place on 9-10 December. Both sides agreed to hold the next UK-EU Cyber Dialogue in London in 2026. Change made: First published. Time updated: 9:56am, 15 December 2025 Copyright and artificial intelligence: progress report Page summary: A progress report on the use of…
Ben Kemp
January 12, 2026
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Update (WC 18th Dec)

Update from business groups on the Employment Rights Bill Page summary: Publication of correspondence between six key business organisations and the Secretary of State for Business and Trade on the Employment Rights Bill. Change made: First published. Time updated: 1:14pm, 15 December 2025 Exporting country guides Page summary: The Department for Business and Trade’s (DBT) guides for UK businesses who…
Ben Kemp
January 12, 2026
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

SHEILD up! Launch of EUR 25 million project to prevent infections from developing into cancer

SHEILD up! Launch of EUR 25 million project to prevent infections from developing into cancer Every year, more than two million people in Europe develop cancer, and one in eight of these cancer cases are caused by an infection that could have been prevented. The SHEILD Joint Action (Strategies for Health Interventions to Eliminate Infection related Cancers) launched today in…
Ben Kemp
January 12, 2026
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