Dear Members, NMPA - China have updated their Medical Device GMP requirements, and this will apply from 1st November 2026 Revision and Release of the Good Manufacturing Practice for Medical Devices
Ben KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026
Dear members the below article highlights the upcoming date of applicability (1 May 2026) of changes to EU Classification Labelling and Packaging (CLP) following adoption of the 22nd ATP. This impacts both product labelling, but also SDS if your products contain impacted substances, subject to mandatory classifications and present above the associated thresholds. Note that this also applies to Northern…
Ben KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026
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 KempJanuary 12, 2026