New legislation on Post-market Surveillance for Medical Devices in Great Britain.

Guidance on the new Medical Devices Post-market Surveillance requirements

Dear Colleague,

A suite of guidance has been published by the Medicines and Healthcare products Regulatory agency (MHRA). This guidance is designed to help medical device manufacturers understand and prepare for the new Post-market surveillance (PMS) regulation for medical devices in Great Britain (GB) which will come into force on the 16^th June 2025.

Key new requirements are enhanced data collection, shorter timelines for reporting serious incidents and summary reporting to enable the MHRA and manufacturers to identify safety issues earlier, as well as clearer obligations for risk mitigation and communication to protect patients and users.

Businesses are encouraged to start using the guidance straight away so that they understand their obligations and are ready to comply with the regulations when they take effect.

Read more in the MHRA’s press release: MHRA guidance on new Medical Devices Post-Market Surveillance requirements - GOV.UK

Please review the PMS guidance

As businesses put the new guidance into use, feedback is welcomed, and we encourage this to be provided through your Trade Association, if you have one, who will be working closely with the MHRA to help identify and address where additional enhancements are needed.

For all other enquiries please contact MHRA at info@MHRA.gov.uk.

Thank you,

The Medicines and Healthcare products Regulatory Agency

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