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
MHRA RegulatoryConnect Webinar Recording MHRA has published the recording of the RegulatoryConnect webinar which took place on 22 May 2025. MHRA RegulatoryConnect Webinar Recording
One Week To Go: MHRA Webinar – An Overview of the New Post-Market Surveillance SI PAGB is hosting a session with MHRA to support members in understanding the new Post-Market Surveillance Statutory Instrument (PMS SI) and guidance. The webinar will take place on Monday 9 June 10.00 to 11.00. One Week To Go: MHRA Webinar – An Overview of the New Post-Market Surveillance SI
JRC Consultation on EU Harmonised Label for Packaging Waste The Joint Research Centre (JRC) of the European Commission has launched a targeted stakeholder consultation as part of their technical work on the harmonised label. The survey aims to gather more detailed feedback on the design aspects of material-based waste sorting labels to be applied to product packaging and waste receptacles across the EU. The deadline to respond is 16 June. JRC Consultation on EU Harmonised Label for Packaging Waste
MHRA Webinar: An Overview of the New Post-Market Surveillance SI PAGB is hosting a session with MHRA to support members in understanding the new Post-Market Surveillance Statutory Instrument (PMS SI) and guidance. The webinar will take place on Monday 9 June 10.00 to 11.00. MHRA Webinar: An Overview of the New Post-Market Surveillance SI
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
EU MDR – Notified Bodies Survey on Certifications & Applications The European Commission has published the Notified Bodies Survey on certifications and applications (EU MDR/IVDR) based on data collected from 51 notified bodies until 31 October 2024 EU MDR – Notified Bodies Survey on Certifications & Applications
New MORE Guidance on Implementing the Changing Data Requirements for Medical Device Reporting To support the implementation of the PMS regulations, MHRA has published new guidance on the changes to GB reporting requirements for serious incidents and field safety corrective actions (FSCA) including an implementation guide which clarifies the changing data requirements and the timelines for compliance. New MORE Guidance on Implementing the Changing Data Requirements for Medical Device Reporting
New EPR Guidance for ‘Small Producers’ Organisations classed as 'small producers' must register and report packaging data annually to comply with the EPR scheme as detailed in the new Defra guidance. New EPR Guidance for ‘Small Producers’
MIR Form 7.3.1 Mandatory from November 2025 The European Commission has published a new version of the manufacturer incident report (MIR) form on its website. This form is mandatory from November 2025. MIR Form 7.3.1 Mandatory from November 2025
