Team NB – Notified Body Perspective on Future Governance in the EU Medical Device Sector Team NB, the European Association of Medical devices - Notified Bodies, has published a position paper on their perspective on future governance in the EU medical device sector. Team NB – Notified Body Perspective on Future Governance in the EU Medical Device Sector
Commission Publishes Updated List of 2025 MDCG Meetings The Commission has published an updated version of planned meeting dates of the MDCG and subgroups for 2025. Commission Publishes Updated List of 2025 MDCG Meetings
MHRA Statutory Fees for Medical Devices Implemented On 16 July, MHRA published the updated fees for medical devices. The existing one-off medical devices registration fee remains and has increased from £240 to £261. MHRA Statutory Fees for Medical Devices Implemented
18th Notified Body Designated Under EU IVDR Poland based notified body ‘POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.’ has become the 18th Notified Body under the EU IVDR. 18th Notified Body Designated Under EU IVDR
DHSC – Review of Patient Safety Across the Health and Care Landscape Dr Penny Dash’s review of patient safety across the health and care landscape in England, which was commissioned by the Department of Health and Social Care (DHSC), has been published. DHSC – Review of Patient Safety Across the Health and Care Landscape
MHRA Medical Devices Standardised Format for PSUR Guidance MHRA has published guidance on the standardised format for the periodic safety update report (PSUR) for medical devices. The guidance contains information and recommendations for manufacturers on the preparation and presentation of a PSUR. MHRA Medical Devices Standardised Format for PSUR Guidance
Launch of European Life Sciences Strategy The European Commission has launched the European Life Science Strategy - 'Choose Europe for life sciences - A strategy to position the EU as the world’s most attractive place for life sciences by 2030'. Launch of European Life Sciences Strategy
MHRA Statutory Fees for Medical Devices to be Implemented on 16 July MHRA is now preparing to publish updated fees for medical devices on 16 July 2025. The existing one-off medical devices registration fee remains, and will increase to £261. MHRA Statutory Fees for Medical Devices to be Implemented on 16 July
MHRA Digital Mental Health Technology Guidance Update MHRA has updated the guidance on qualification and classification of digital mental health technology. This guidance is intended to help manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification. MHRA Digital Mental Health Technology Guidance Update
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
