Guidance

Medical devices: Standardised format for the post market surveillance report

Information and recommendations for manufacturers on the preparation and presentation of a post market surveillance report (PMSR).

From:
Medicines and Healthcare products Regulatory Agency
Published
5 September 2025

Documents

Medical devices: Standardised format for the post market surveillance report

PDF, 630 KB, 17 pages

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Details

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

Updates to this page

Published 5 September 2025

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