EU MDR – Commission Publishes Updated Overview on Applications for Designation as a NB The European Commission has published an updated version of the overview of the applications for designation as a Notified Body (NB) under the EU MDR and IVDR. EU MDR – Commission Publishes Updated Overview on Applications for Designation as a NB
MHRA AI Airlock Webinar Recording MHRA has shared a link to the latest MHRA webinar recording - 'AI Airlock webinar – Pilot and Phase 2' which took place on 19 June 2025. MHRA AI Airlock Webinar Recording
MDCG EUDAMED – Production Release 2.15 Successfully Deployed The EUDAMED Production release 2.15 (Actors registration, UDI/Devices and NBs & Certificates modules) has been successfully deployed. MDCG EUDAMED – Production Release 2.15 Successfully Deployed
New MHRA MedTech Blog Post MHRA has published the June edition of the MedTech blog. New MHRA MedTech Blog Post
European Commission Implementing Regulation on Electronic Instructions for Use for Medical Devices Published in Official Journal The Commission Implementing Regulation (EU) 2025/1234 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form has been published in the Official journal. European Commission Implementing Regulation on Electronic Instructions for Use for Medical Devices Published in Official Journal
MHRA AI Airlock Pilot (Medical Devices) – Phase 2 testing MHRA has announced that their Phase 2 AI Airlock testing is open for applications. Applications are open from 23 June to 12 July 2025. MHRA AI Airlock Pilot (Medical Devices) – Phase 2 testing
MDCG – Guidance on Medical Device Software (MDSW) Apps on Online Platforms The Medical Device Coordination Group (MDCG) 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps on online platforms has been published on the European Commission website. MDCG – Guidance on Medical Device Software (MDSW) Apps on Online Platforms
EUDAMED – Stuttgart Event Recordings Available On 21 May a hybrid event on EUDAMED was held in Stuttgart. The purpose of this session was to support the EUDAMED onboarding, to prepare for compliance with the Regulations in view of its mandatory use. The recordings of the event have now been published. EUDAMED – Stuttgart Event Recordings Available
MHRA Safety Roundup May 2025 MHRA's safety bulletin, the MHRA Safety Roundup, for May 2025 has been published. This includes a summary of all safety alerts (including Drug Safety Updates) published during the month for medicines and medical devices. MHRA Safety Roundup May 2025
EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch As part of the COMBINE programme, Member State authorities have launched a pilot to test a new, more efficient way of approving combined studies. EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch
New Post-Market Surveillance Regulation In Force As of 16 June, the new Post-Market Surveillance regulation for medical devices takes effect. The new regulation applies to all UKCA- and CE-marked devices placed on the GB market from 16 June 2025. New Post-Market Surveillance Regulation In Force
MHRA Guidance Update: Medical Devices Post-market Surveillance and Vigilance The new Post-market Surveillance and Vigilance regulations for medical devices will come into force on 16 June 2025. MHRA has published the final data standards and guidance for Manufacturer Incident Reports (MIRs) and Field Safety Corrective Actions (FSCAs) in Great Britain (GB), for the upcoming GB reporting requirements. In addition, a short presentation on the changing regulations providing further clarifications following stakeholder feedback has been shared. MHRA Guidance Update: Medical Devices Post-market Surveillance and Vigilance
