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
FSA Consultation – Proposed BPA Ban, Alignment With the EU The FSA has launched a public consultation seeking stakeholders’ views on their proposal to implement a ban on the use of bisphenol A (BPA) and other bisphenols in food contact materials (FCMs). The consultation will close on 24 December 2025. FSA Consultation – Proposed BPA Ban, Alignment With the EU
51st Notified Body Designated Under the EU MDR Slovenia-based Notified Body ‘NOTICE, storitve ugotavljanja skladnosti, d.o.o.’ has been notified as the 51st Notified Body under the EU MDR. 51st Notified Body Designated Under the EU MDR
AESGP Webinar – Evaluating Credibility in Digital Campaigns AESGP is hosting a webinar on “Evaluating credibility in digital campaigns: a practical guide and example with Influencer Monitor" on 24 November. AESGP Webinar – Evaluating Credibility in Digital Campaigns
Mandatory Use of New GB Schemas From 16 October 2025, all medical device manufacturers must use the new Great Britain data schemas when reporting safety incidents to the MHRA. Mandatory Use of New GB Schemas
MedTech Europe Position Paper on eIFU for Certain Medical Devices Intended for Lay Users Published MedTech Europe has published a position paper outlining calls to expand electronic Instructions for Use (eIFU) to certain lay-use devices, building on recent regulatory updates and supporting the EU’s Green Deal goals. MedTech Europe Position Paper on eIFU for Certain Medical Devices Intended for Lay Users Published
