MHRA – Adverse Event Reporting in DMHTs and Development of Updates to Regulatory Guidance The MHRA has published guidance for manufacturers of digital mental health technologies (DMHTs) that qualify as software as a medical device (SaMD) on understanding new post marketing surveillance rules and examples of how they apply. MHRA – Adverse Event Reporting in DMHTs and Development of Updates to Regulatory Guidance
UK REACH: Rationale for priorities 2025-2026 Defra, and the Scottish and Welsh Governments have set out a rationale for the UK REACH work programme for the 2025-2026 financial year. UK REACH: Rationale for priorities 2025-2026
MHRA Publishes Statement of Policy Intent: Early Access to Innovative Medical Devices The MHRA is setting out its intention to enable earlier access to innovative medical devices that address unmet clinical needs within the NHS. MHRA Publishes Statement of Policy Intent: Early Access to Innovative Medical Devices
EU-US Trade Deal Agreement – Tariffs Impact On 27 July 2025, the EU and US reached an agreement on a EU-US trade deal, covering import and export tariffs and other trade regulations. EU-US Trade Deal Agreement – Tariffs Impact
Government’s Response to the Consultation on Future Routes to Market for Medical Devices in Great Britain MHRA has published the government’s response to its public consultation on future routes to market for medical devices in Great Britain setting out MHRA's response to the proposals relating to international reliance, UKCA marking and the regulation of Class B in vitro diagnostic devices. Government’s Response to the Consultation on Future Routes to Market for Medical Devices in Great Britain
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
