Fulfil one of medical device regulation's most critical ongoing obligations with our comprehensive Periodic Safety Update Report (PSUR) Template — a professionally structured, audit-ready document designed to help manufacturers demonstrate continued device safety and performance to notified bodies and regulatory authorities at each required reporting interval.

The PSUR is a mandatory requirement under EU MDR, EUIVDR and UK Medical Devices PMS Regulation 2024, and this template ensures your organisation can meet that obligation with a report that is thorough, consistent, and built to withstand regulatory scrutiny. Rather than building your report from scratch each cycle, this template gives your team a reliable, repeatable structure that captures all required content in the format regulators expect.

The template opens with a polished cover page and executive summary, setting the tone for a report that communicates clearly and professionally to its intended audience. It then moves into the commercial and epidemiological context that underpins your safety conclusions — covering volume of sales, estimated population size, and how the characteristics of the device-using population have evolved over time. A section on similar devices on the market ensures your benefit-risk assessment is properly contextualised against the current clinical and competitive landscape.

The heart of the PSUR lies in its safety data sections, and this template covers them all. Structured sections for serious incident analysis, other incidents, and side effects — capturing both positive and negative effects — ensure a complete picture of device safety in the field. Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs) are documented and assessed, while dedicated trend analysis and CAPA sections ensure that emerging patterns are identified, investigated, and resolved with appropriate rigour.

For software-based and connected medical devices, the template includes specialist sections on Software of Unknown Provenance (SOUP) review and cybersecurity monitoring and threat assessment, addressing the distinct and growing risk profile of digital health products in a way that many generic templates fail to do.

Post-market evidence is drawn together from a wide range of sources, with structured sections for user and supplier feedback and complaints, scientific and specialist literature reviews, public database searches, post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) studies, and surveys. The overall assessment of PMCF and PMPF activities, combined with sections on data validity and overall conclusions, ensures that all evidence streams are properly integrated and evaluated before final conclusions are drawn.

The template concludes with a clear account of actions taken by the manufacturer, full report history tracking, and submission details for notified bodies and UK approved bodies — making it equally suitable for use under both EU MDR/IVDR and UK regulatory frameworks. Fully customisable to your specific device, organisation, and reporting period, this template provides the structure and consistency your team needs to produce high-quality PSURs with confidence, every reporting cycle.