DHSC 10 Year Health Plan Collection DHSC has published a collection related to the 10 Year Health Plan for England. The Government committed to co-developing the plan with members of the public, health and care staff and partner organisations and to do this, Change NHS was launched. The findings of Change NHS are included in the collection. DHSC 10 Year Health Plan Collection
One Substance One Assessment – Publication of Regulations The One Substance, One Assessment (OSOA) regulations have been published in the EU Official Journal. One Substance One Assessment – Publication of Regulations
EMA – Updated Q&A on Drug Device Combination Products (Dec 2025) The European Medicines Agency (EMA) has updated its Questions and Answers on Drug Device Combination Products (6th revision). EMA – Updated Q&A on Drug Device Combination Products (Dec 2025)
Overview on Applications for Designation as a Notified Body Updated The overview on the applications for designation as a notified body under the EU MDR and IVDR has been updated by the European Commission. Overview on Applications for Designation as a Notified Body Updated
MHRA and the Department of Health Northern Ireland MHRA and Northern Ireland partners have announced a strengthened programme of collaboration designed to support innovation, enhance patient safety and ensure people in Northern Ireland continue to benefit from world-class regulation of medicines and medical technologies. MHRA and the Department of Health Northern Ireland
MHRA Launches Paid Regulatory Advice Service for Medical Devices MHRA has now published guidance on its new regulatory advice meeting service for medical devices and IVDs in Great Britain. MHRA Launches Paid Regulatory Advice Service for Medical Devices
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
