Periodic Safety Update Report Procedure | ISO 9001:2026 + ISO 13485:2016
Prepare, review, approve and update EU MDR Periodic Safety Update Reports for applicable device classes. This editable periodic safety update report procedure is part of the A.P. Lyon Dual-Standard QMS family for ISO 9001:2026 and ISO 13485:2016, and now comes with a companion PSUR completion guide and checklist.
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Scope and intended use
This procedure applies to EU Class IIa, IIb and III medical devices for which a PSUR is required, including applicable implantable devices. For legacy and custom-made devices, apply current MDR transitional requirements and Commission guidance. U.S. feedback, complaint and improvement processes feed the quality management system but do not by themselves create an EU PSUR obligation.
What you receive
One digital ZIP containing:
SOP 8-013-C Periodic Safety Update Report (PSUR) Procedure — editable Word procedure with a PDF copy.
GUIDE 8-013-C PSUR Completion Guide and Checklist — editable Word guide with a PDF copy. Part A walks through PSUR frequency and submission route by device class, device grouping and the leading device, the PMS data inventory, sales and population estimates, a section-by-section writing table and common mistakes. Part B is a 28-item sign-off checklist. It also shows how PSUR conclusions feed data analysis, corrective action and management review under ISO 9001:2026 and ISO 13485:2016.
The gallery shows representative pages from the procedure. No separate editable form or controlled-list files are included in this individual ZIP.
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.
Related procedures
These procedures address connected work and are sold separately:
Systems containing this procedure
A system package includes this procedure with other documents. Review its content list before purchasing both.
Before implementation
Adapt responsibilities, process steps, acceptance criteria and records to your organization, device and intended markets. Confirm the applicable standards and regulatory requirements before approval and use. This download supplies documentation, not executed testing, regulatory authorization or certification.
