UK publishes new model periodic safety report (PSUR) for medical devices - MHRA 2024
The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom published, in June 2025, the updated document “The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024”, which introduces a new standardized model for drafting the Periodic Safety Update Report (PSUR) for medical devices placed on the British market.
This document aims to harmonize the structure and content of PSURs submitted by manufacturers, in order to improve the quality of post-market surveillance (PMS) and the effectiveness of assessments conducted by the authorities.
What changes with the new PSUR model?
The new guidance provides detailed instructions on the information that must be included in PSURs, including:
Identification and characterization of the devices covered by the report, including changes compared to previous versions;
Information on exposure — number of devices marketed and user population profile;
Device performance data, including surveillance (serious incidents, corrective actions, trends);
Proactive analysis of clinical data, PMCF (Post-Market Clinical Follow-up), and other real-world data sources;
Comparison with similar devices available on the market;
Detailed description of preventive and corrective actions (CAPA);
Conclusions on the device’s benefit-risk profile and any actions to mitigate identified risks.
Objectives and impact for manufacturers
The introduction of this standardized model has the following main objectives:
Facilitate comparative analysis of safety and performance data, year after year;
Promote greater consistency in post-market surveillance of medical devices;
Support the continuous improvement of product safety in the British market.
Although the new format is not mandatory (manufacturers may adapt or justify the non-inclusion of certain sections), the MHRA strongly encourages its adoption, with the aim of standardizing submissions and facilitating compliance assessments.
