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

Applies to England, Scotland and Wales

Documents

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation

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

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

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Details

Guidance on the regulations The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

These regulations amend the UK medical devices regulations by adding post-market surveillance requirements for medical devices, including in vitro diagnostic devices and active implantable medical devices.

Published 15 January 2025