MHRA – First Chief Medical and Scientific Officer Appointed Professor Jacob George has been appointed as the first Chief Medical and Scientific Officer for MHRA. MHRA – First Chief Medical and Scientific Officer Appointed
UK Regulator Dashboard Published The Department for Business and Trade has published the UK Regulator Dashboard containing information and KPIs from 16 UK regulators, published as part of the government’s Regulatory Action Plan. UK Regulator Dashboard Published
MHRA Safety Roundup October 2025 MHRA's safety bulletin, the MHRA Safety Roundup, for October 2025 has been published. MHRA Safety Roundup October 2025
EUDAMED – Production Release 2.18 EUDAMED Production release 2.18 (Actors, UDI/Devices and NBs & Certificates modules) has been successfully deployed. EUDAMED – Production Release 2.18
19th Notified Body Designated Under EU IVDR Finland based notified body ‘SGS FIMKO OY’ has been notified as the 19th Notified Body under the IVDR. 19th Notified Body Designated Under EU IVDR
MHRA AI Airlock – Phase 2 Cohort Guidance The MHRA has announced that seven emerging AI healthcare technologies have been selected for the second phase of their AI Airlock programme. MHRA AI Airlock – Phase 2 Cohort Guidance
MHRA AI Airlock – Pilot phase reports MHRA has shared reports on their AI Airlock Sandbox Pilot Programme as well as on three Simulation workshops that were held during the pilot phase. MHRA AI Airlock – Pilot phase reports
EU Study Launched on Medical Device Shortages The European Commission has commissioned a study to analyse medical device supply chain vulnerabilities and shortage management. EU Study Launched on Medical Device Shortages
Defra Consults on 2025 WEEE Compliance Fee Defra has launched a four-week consultation (closing 10 November 2025) on whether to set a compliance fee for the 2025 compliance period under the UK Waste Electrical and Electronic Equipment (WEEE) Regulations 2013. Defra Consults on 2025 WEEE Compliance Fee
New Medical Device Registration Fee Structure – Guidance Published MHRA has published an update to the Register medical devices to place on the market guidance, reflecting the upcoming implementation of the new annual fee structure for medical device registrations. New Medical Device Registration Fee Structure – Guidance Published
Updated BHTA / BIVDA / PAGB Guide to UK Medical Device Registration and Marking PAGB has published an updated version of the BHTA / BIVDA / PAGB Guide to UK Medical Device Registration and CE / UKCA / UKNI Marking. Updated BHTA / BIVDA / PAGB Guide to UK Medical Device Registration and Marking
EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings The European Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. EU Medical Devices – Updated Schedule for 2025 MDCG and Subgroup Meetings
