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

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

Showing diff : 2025-01-15 10:00:43.800509842 +00:00..2025-06-16 09:02:46.936993721 +00:00

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 — See all updates

Applies to England, Scotland and Wales

Documents

TheIntroduction Medicaland Devicesscope

HTML

Requirements (Post-marketof Surveillancethe Requirements)manufacturer's (Amendment)PMS (Great Britain) Regulations 2024: guidance on implementation system

HTML

Vigilance reporting requirements

HTML

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

HTMLPDF, 364 KB, 7 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

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

HTMLPDF, 405 KB, 10 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

GuidanceThe onnew theset of regulations The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

These regulationsamends amend the UK medicalMedical devicesDevices regulationsRegulations 2002 (MDR 2002) by addinginserting a new Part 4A on post-market surveillance (PMS) requirements for medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices.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 href="#full-history">+ show all updates

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

  2. First published.

Sign up for emails or print this page

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.