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
16 June 2025 鈥� See all updates

Documents

Introduction and scope

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Requirements of the manufacturer's PMS system

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Vigilance reporting requirements

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PDF, 364 KB, 7 pages

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PDF, 405 KB, 10 pages

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Details

皇冠体育app new set of regulations 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 16 June 2025 show all updates

  1. Updated to reflect the coming into force of 皇冠体育app Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  2. First published.

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