MHRA Welcomes Chief Medical and Scientific Officer The MHRA has welcomed Professor Jacob George as he started as Chief Medical and Scientific Officer (CMSO) on 5 January. MHRA Welcomes Chief Medical and Scientific Officer
52nd Notified Body Designated Under the EU MDR The Malta-based Notified Body ‘Malta Conformity Assessment Ltd.’ has been notified as the 52th Notified Body under the EU MDR. 52nd Notified Body Designated Under the EU MDR
Government Response: Disclosure of Industry Payments to Healthcare Sector The Department of Health and Social Care (DHSC) has published the Government response to the public consultation which ran in 2023 to seek the views of individuals and organisations in relation to disclosure of industry payments to the healthcare sector. Government Response: Disclosure of Industry Payments to Healthcare Sector
Defra Guidance – Plastic Wet Wipes Ban The Department for Environment, Food & Rural Affairs (Defra) has published guidance on the plastic wet wipes ban. Defra Guidance – Plastic Wet Wipes Ban
Updated MIR 7.3.1 Published – Mandatory Use from May 2026 The European Commission has released the final version of the Manufacturer Incident Report (MIR) form, version 7.3.1. Mandatory use of this version begins 01 May 2026. Updated MIR 7.3.1 Published – Mandatory Use from May 2026
New MDCG Guidance on Breakthrough Devices Published The European Commission has published the MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under the MDR and IVDR. New MDCG Guidance on Breakthrough Devices Published
Independent Review of Windsor Framework Published The UK Government has published the Independent Review of the Windsor Framework, assessing its operation since implementation. The review examines economic, social, and regulatory impacts, with implications for post-Brexit divergence and compliance requirements affecting UK businesses. Independent Review of Windsor Framework Published
MDCG Post-market Surveillance of Medical Devices Guidance Published The European Commission has published the Medical Device Coordination Group (MDCG) 2025-10 guidance on post-market surveillance (PMS) of medical devices and in vitro diagnostic medical devices. MDCG Post-market Surveillance of Medical Devices Guidance Published
MHRA Call for Evidence on AI Regulation in Healthcare MHRA has launched a Call for Evidence to inform the National Commission on the Regulation of AI in Healthcare. This initiative aims to shape a framework that safeguards patients while enabling responsible innovation and growth across the HealthTech sector and NHS. Responses are invited from all stakeholders, including patients, professionals, and industry innovators, by 2 February 2026. MHRA Call for Evidence on AI Regulation in Healthcare
Publication of EC Legislative Proposal to Amend the EU MDR The European Commission has published its legislative proposal for amending the MDR and IVDR which aims to aims to streamline and future-proof the EU regulatory framework. Publication of EC Legislative Proposal to Amend the EU MDR
EC Annex VII Proposal and Team-NB Position The European Commission has published a draft Implementing Regulation introducing uniform requirements for notified bodies under MDR/IVDR, including strict timelines, transparency obligations, and monitoring systems. Team-NB has issued a position paper highlighting feasibility concerns and calling for pragmatic timelines. EC Annex VII Proposal and Team-NB Position
Designated Standards: Medical Devices Proposal to Amend The Office for Product Safety and Standards has shared that the Department of Health and Social Care (DHSC) has issued a notice of proposal to publish references to standards for medical devices in support of the Medical Devices Regulations 2002 (S.I. 2002/618). Designated Standards: Medical Devices Proposal to Amend
