Periodic Safety Update Report (PSUR) Procedure

Prepare, review, approve and document EU MDR Periodic Safety Update Reports (PSURs) with this editable Periodic Safety Update Report Procedure and its companion PSUR Completion Guide and Checklist.

Building a set? Buy procedures from the same family together and save: 5–9 for 20% off, 10–19 for 35%, 20–39 for 50%, or 40+ for 60%. The discount is applied automatically in your cart, or use Build Your QMS to choose and price a set.

What your download includes

Two editable Microsoft Word documents, supplied as a digital download:

• SOP 8-013 Periodic Safety Update Report (PSUR) Procedure — a structured process for preparing, reviewing, approving and documenting periodic safety update reports.

• PSUR Completion Guide and Checklist — step-by-step guidance for confirming the PSUR obligation and route, setting the data collection period, building the PMS data inventory, presenting sales and population data, writing each PSUR section and supporting the benefit-risk conclusion, plus a 27-item checklist covering planning, data, conclusions, approval and filing.

What the PSUR procedure covers

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.

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.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Post-Market Surveillance and PSUR Planning for workflow guidance, a checklist and common mistakes.