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).

From:
Medicines and Healthcare products Regulatory Agency
Published
15 January 2025

Applies to England, Scotland and Wales

Documents

Periodic safety update reports (regulation 44ZM) for approved bodies

HTML

PDF, 440 KB, 15 pages

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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

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