Updated EUDAMED Timelines – November 2025 Following publication of the notice of functionality of the first four EUDAMED - the European Database on Medical Devices IT system - modules (Actors, UDI/Devices, NB/Certificates and Market Surveillance) in the Official Journal of the European Union the EUDAMED timelines have been updated to reflect these changes. Updated EUDAMED Timelines – November 2025
EMA – Updated Q&A on Drug Device Combination Products The European Medicines Agency (EMA) has updated its Questions and Answers on Drug Device Combination Products. EMA – Updated Q&A on Drug Device Combination Products
Persistent Organic Pollutants – Stockholm Convention Updates, UK & EU Implementation Timelines The Department for Environment, Food and Rural Affairs (Defra) has shared information and updates relating to the implementation of decisions recently made by Conference of the Parties (COP) to the Stockholm Convention Persistent Organic Pollutants – Stockholm Convention Updates, UK & EU Implementation Timelines
New MHRA Blog Outlines Innovative MedTech Regulatory Reforms MHRA’s latest blog highlights progress on AI integration, updated guidance for Health Institution Exempted devices, and upcoming consultations on CE mark recognition and pre-market legislation. New MHRA Blog Outlines Innovative MedTech Regulatory Reforms
EUDAMED – Functionality and Mandatory Modules Commission Decision (EU) 2025/2371 regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices (EUDAMED), was published in the Official Journal of the EU. EUDAMED – Functionality and Mandatory Modules
EU Digital Package Targets Compliance Simplification The European Commission has unveiled a comprehensive digital package aimed at reducing administrative burdens for businesses and fostering innovation. Key measures include streamlined AI, cybersecurity, and data rules, a new Data Union Strategy, and European Business Wallets to simplify cross-border operations. EU Digital Package Targets Compliance Simplification
UK – EM on EU Regulation Amending Regulation (EU) 2019/1021 on Persistent Organic Pollutants The government has provided an Explanatory Memorandum (EM) summary relating to a proposed EU Regulation Amending Regulation (EU) 2019/1021 on persistent organic pollutants. UK – EM on EU Regulation Amending Regulation (EU) 2019/1021 on Persistent Organic Pollutants
MHRA Blog Post Outlines Future Vision for AI Regulation in Healthcare Professor Alastair Denniston has set out the UK’s vision for regulating AI in healthcare in a newly published MHRA blog post. MHRA Blog Post Outlines Future Vision for AI Regulation in Healthcare
DHSC Publishes Men’s Health Strategy for England DHSC has published the first Men’s Health Strategy for England which prioritises prevention, early intervention, and reducing health inequalities. DHSC Publishes Men’s Health Strategy for England
Joint Statement on Digital Label for Authorised Representative and Importer Published AESGP, alongside MedTech Europe, COCIR, and Euromcontact, issued a joint statement urging EU legislators to permit digital labelling for authorised representative (AR) and importer details on medical devices and IVDs. Joint Statement on Digital Label for Authorised Representative and Importer Published
Call for Evidence to Unlock Business The Department for Business and Trade (DBT) and the Treasury published a call for evidence asking businesses to tell the Government about regulation which is not fit for purpose and unjustifiable inhibits growth, innovation and investment. Call for Evidence to Unlock Business
Animal Testing – UK Roadmap for Alternative Methods Animal testing in science is set to be phased out faster under a new plan to deliver on the government’s manifesto commitment, unveiled by Science Minister Lord Vallance on 11 November. Animal Testing – UK Roadmap for Alternative Methods
