Guidance

Medical devices: periodic safety update report (PSUR)

Information and recommendations on the presentation and review of a PSUR

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

Applies to England, Scotland and Wales

Documents

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies

HTML

Medical devices: periodic safety update report (PSUR) formatting

PDF, 440 KB, 15 pages

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Details

Detailed guidance for approved bodies on reviewing and formatting periodic safety update reports (PSURs) and a standardised format for PSURs.

Published 15 January 2025