With the entry into force of the "Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024" on June 1, 2025, the United Kingdom is tightening its requirements for the market surveillance of medical devices. The focus is on the introduction of a standardized format for the Periodic Safety Update Report (PSUR).
Manufacturers of Class IIa, IIb, and III medical devices, as well as active implantable medical devices (AIMDs), are now required to prepare PSURs according to clearly defined content and format specifications. The aim is to improve post-market surveillance, ensure consistent reporting, and increase transparency for the competent authority.
The MHRA provides structured templates to support consistent implementation. Manufacturers should review and adapt their post-market surveillance processes to meet the new regulatory requirements.
Further information, including templates and implementation guidance, can be found on the MHRA website – Medical Devices: Periodic Safety Update Report
