The MHRA has released new guidance to help medical device manufacturers comply with the upcoming Post-Market Surveillance (PMS) regulations in Great Britain.

These regulations aim to enhance patient safety by requiring manufacturers to collect more data, report serious incidents faster, and take clear steps to mitigate risks. The guidance also explains how the regulations will apply to different types of medical devices based on their risk level.

Key points of the guidance include:

  • Medical device manufacturers must comply with the new PMS regulations by 16th June 2025.

  • Key changes to manufacturer requirements include enhanced data collection, faster reporting, and clearer risk mitigation strategies.

  • The regulations will apply to all medical devices used in Great Britain, but requirements will vary based on risk level.

  • The MHRA encourages manufacturers to start using the guidance ahead of time to ensure they are ready to comply with the regulations when they take effect.

A summary of the main changes can be found here, and more detail on the obligations by medical device type can be found here.

Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said:

“The new Post-Market surveillance regulations will provide us with more safety information on medical devices in use in GB, allowing us to act swiftly when needed to reduce potential harm. This will enable not only the MHRA, but the whole health system, to better protect patients. Manufacturers should start using the guidance straight away so that they are ready to comply with the regulations. Feedback is encouraged and will help us to address additional enhancements should they be needed.”

The Health Tech Alliance will be collating feedback from its members on the above topic.