Periodic Safety Update Report (PSUR) Procedure

Complete PSUR Documentation Package — editable Microsoft Word files supplied as an immediate digital download for integration into your quality system.

This package combines an editable PSUR procedure with practical completion guidance and a working checklist for medical device post-market surveillance.

Your download includes:

• Periodic Safety Update Report (PSUR) Procedure — editable Microsoft Word procedure providing a structured process for preparing, reviewing, approving, and documenting periodic safety update reports.

• PSUR Completion Guide — practical guidance for organizing device scope, exposure data, PMS findings, complaints and vigilance signals, CAPA and safety actions, PMCF/clinical information, benefit-risk conclusions, follow-up actions, review, and approval.

• PSUR Completion Checklist — working checklist for key preparation, analysis, review, approval, traceability, and retention activities.

The procedure addresses reporting periods and device scope, device exposure, worldwide market status, post-market findings, complaints and vigilance signals, safety actions, clinical findings, analysis of collected information, benefit-risk assessment, documented conclusions, and rationale for follow-up actions.

Regulatory foundation: Developed with reference to Regulation (EU) 2017/745 (MDR), including Article 86, and current applicable MDCG guidance for PSUR preparation and post-market surveillance.

Editable Word Documents • Medical Device Focus • EU MDR Referenced • QMS-Ready Format • Immediate Digital Download

Adapt and implement these documents for your device, activities, organization, and markets. Purchasing documentation does not by itself establish regulatory compliance or certification.

Related documents for this workflow

• Organize the continuing PMS process that supplies the report. Post Market Surveillance Procedure.

• Define the clinical follow-up activities that generate planned post-market evidence. Post-Market Clinical Follow-Up Plan.

• Document PMCF findings that may inform PSUR conclusions. Post-Market Clinical Follow-Up Evaluation Report.

• Carry post-market clinical evidence into the ongoing clinical evaluation. Clinical Evaluation Procedure.