Guidance

Medical devices: Standardised format for the periodic safety update report

Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).

• From: Medicines and Healthcare products Regulatory Agency
• Published: 3 July 2025

Documents

Medical devices: Standardised format for periodic safety update report (PSUR)

PDF, 442 KB, 17 pages

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Details

This document is intended to guide manufacturers on what data to include within a periodic safety update report (PSUR). It is not mandatory to include sections which do not apply, and data may be displayed in an alternative form if appropriate.

Published 3 July 2025