Meet your post-market reporting obligations with confidence using our comprehensive Post-Market Surveillance (PMS) Report Template — a fully structured, audit-ready document designed for medical device manufacturers who need to demonstrate ongoing device safety, performance, and compliance to notified bodies and regulatory authorities.

This template guides your team through every section required for a thorough and defensible PMS Report, from executive summary to final submission details. It is built to support the complete post-market surveillance reporting cycle, ensuring no critical area is overlooked and that your report reflects the depth of analysis regulators expect.

The template covers commercial and epidemiological context, including volume of sales, estimated population size, and how the characteristics of that population may shift over time — providing the real-world backdrop against which your device's performance must be assessed. A dedicated section on similar devices on the market ensures your benefit-risk conclusions are grounded in the broader competitive and clinical landscape.

On the safety side, the template provides structured sections for serious incident analysis, other incident analysis, and side effects — both positive and negative — as well as Field Safety Corrective Actions (FSCAs) and Field Safety Notices (FSNs). Trend analysis and CAPA sections ensure that patterns are identified, acted upon, and properly documented.

For digital health and software-based medical devices, dedicated sections on Software of Unknown Provenance (SOUP) review and cybersecurity monitoring and threat assessment ensure your report addresses the unique risks of connected and software-driven products.

The template also covers the full range of post-market data sources, including user and supplier feedback, complaints, scientific and technical literature reviews, public database searches, post-market clinical follow-up (PMCF) or post-market performance follow-up (PMPF) studies, and surveys. Sections on data validity and overall conclusions bring all collected evidence together into a coherent, regulator-ready assessment, culminating in a clear account of actions taken by the manufacturer.

Finalised with report history tracking and submission details for notified bodies and UK approved bodies, this template is suitable for use under both EU MDR/IVDR and UK regulatory frameworks. Fully customisable to your device and organisation, it provides the structure your team needs to produce consistent, high-quality PMS Reports year after year.