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
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 Marketing Authorisations Granted 1 to 14 November 2025 MHRA granted 4 OTC licences during 1 - 14 November 2025. MHRA Marketing Authorisations Granted 1 to 14 November 2025
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
CMDh November 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from their meeting held on 11-13 November 2025. CMDh November 2025 Meeting – Report
MHRA Performance Data – October 2025 MHRA has published its performance data for October 2025. MHRA Performance Data – October 2025
Parliamentary Question on Asthma Medical Equipment Following a parliamentary question, DHSC confirmed inhalers remain prescription-only. MHRA invites major applications for reclassification, supporting innovation while ensuring safety and clinical oversight. Parliamentary Question on Asthma Medical Equipment
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
