Guidance
Medical devices: periodic safety update report
Information and recommendations for approved bodies on the presentation and review of a periodic safety update report (PSUR).
Documents
Details
This guidance is for approved bodies who are required to receive and review a PSUR from manufacturers of medical devices.
You can find information on:
- the relevant regulations
- what a review should include
- when a review is not needed
- how to write and submit the report
Updates to this page
Published 15 January 2025
Last updated 18 June 2025
show all updates
-
Added periodic safety update report
-
Updated PDF 'Medical devices periodic safety update report (PSUR)'
-
First published.