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Ben Kemp

FDA updates Regulatory Affairs NewsletterFDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

FDA Guidance updates

Dear Members, please note the following FDA Guidance Document updates issued since 15/12/2025: Final Guidance: Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices | FDA Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices | FDA Processes and Practices Applicable to Bioresearch Monitoring Inspections | FDA Clinical Decision Support Software | FDA General Wellness: Policy for…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025L2647: Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302, (EU) 2019/2161 a

Dear Members, please see below updated EU legislation regarding Consumer Protection and dispute resolution. This impacts Business to Consumer transactions e.g for self-test devices, and includes digital products and services. Directive (EU) 2025/2647 of the European Parliament and of the Council of 16 December 2025 amending Directive 2013/11/EU on alternative dispute resolution for consumer disputes and amending Directives (EU) 2015/2302,…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

CELEX:32025R2605: Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation (EU) No 952/2013 of the European Parliament

Dear members, please note that the EU has updated it’s list of common customs tariffs which have been suspended for imports into the EU. This includes chemicals and components used in electronics etc. Council Regulation (EU) 2025/2605 of 12 December 2025 amending Regulation (EU) 2021/2278 suspending the Common Customs Tariff duties referred to in Article 56(2), point (c), of Regulation…
Ben Kemp
January 12, 2026
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
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