Change of https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements

Change description : 2025-09-05 15:14:00: Added link to guidance for ‘Medical Devices: Standardised format for post market surveillance report (PMSR)’ [Guidance and regulation]

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Guidance

Medical devices: post-market surveillance requirements

How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.

From:
Medicines and Healthcare products Regulatory Agency
Published
15 January 2025
Last updated
165 JuneSeptember 2025 — See all updates

Documents

Introduction and scope

HTML

Requirements of the manufacturer's PMS system

HTML

Vigilance reporting requirements

HTML

Post-market surveillance requirements for medical devices: summary of main changes

PDF, 364 KB, 7 pages

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Post-market surveillance (PMS) obligations by medical device type

PDF, 405 KB, 10 pages

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Details

The new set of regulations The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Devices Regulations 2002 (MDR 2002) by inserting a new Part 4A on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices which apply within Great Britain (GB). It includes notification requirements for incidents, and preventive and corrective actions taking place after the device is first approved for the GB market.

Updates to this page

Published 15 January 2025
Last updated 165 JuneSeptember 2025 + show all updates

  2. Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

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Update history

2025-09-05 15:14
Added link to guidance for ‘Medical Devices: Standardised format for post market surveillance report (PMSR)’

2025-06-16 10:00
Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

2025-01-15 10:00
First published.