Description:
This Periodic Safety Update Report (PSUR) template helps us summarize post-market data for a defined period and conclude on ongoing safety, performance, and benefit-risk.

• Define Basic UDI-DI / EUDAMED DI(s), device scope, and a data collection period.

• Capture PSUR submission in EUDAMED (date, timeliness, reference number) when applicable.

• Document grouping of devices using MDCG 2022-21 principles and justify the leading device.

• Quantify volume of sales and estimate population size and characteristics.

• Analyze vigilance, trend reporting, FSCA, and CAPA outputs with traceable tables.

• Run literature search using PICO and structured screening, as applicable.

• Screen public databases (e.g., FDA MAUDE) and map findings to risk management conclusions.

Your needs:

• Periodic Safety Update Report

• Periodic Safety Update Report for MDR compliance

• Reduce rework, tighten timelines, and strengthen notified body readiness.

This template is used to compile PMS evidence into one controlled PSUR that supports lifecycle decisions, including grouping, data validity, and resulting actions.

It covers structured PMS outputs. Basic UDI-DI anchors device family traceability; it matters because PSUR scope and certificates are mapped to it. Trend reporting evaluates statistically meaningful increases; it matters because it can trigger regulatory notification.

• Define scope, grouping rationale, and leading device selection.

• Quantify sales/usage and population estimates by region.

• Summarize serious incidents, investigation findings, and health impacts.

• Evaluate FSCA and CAPA status with effectiveness conclusions.

• Compare risks to thresholds and document new/emerging risks.

• Record benefits review and overall PSUR conclusions.

At Lexqara, we build PSUR-ready PMS workflows, align tables to your complaint/CAPA logs, and ensure traceability to risk management and clinical documentation. Resource Center [https://lexqara.com/resource-center] and Post-Market Surveillance support [https://lexqara.com/services/post-market-surveillance]. MDCG 2022-21 guidance [https://health.ec.europa.eu/system/files/2022-12/mdcg_2022-21_en.pdf]. Download the template or request a short gap assessment.