Medical devices: post-market surveillance
Information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.
In 2024, the government put in place legislation to clarify and strengthen the post-market surveillance requirements for medical devices in use in Great Britain. These measures will come into force on 16 June 2025 and will facilitate greater traceability of incidents and trends and allow the MHRA to act swiftly when needed, supporting better risk management and containment of safety issues and reducing harm.
The new set of regulations The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 amends the UK Medical Devices Regulations (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 in 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.
The regulations apply to Great Britain (England, Wales and Scotland). Medical devices placed on the market or put into service in Northern Ireland (NI) must follow the post-market surveillance rules set out in EU medical devices regulations as explained by guidance on the Regulation of devices in Northern Ireland.
This information is designed to help you understand the main changes that implementing the post-market surveillance regulations will introduce for medical devices and what you need to do to prepare.
Updated MORE guidance will be available in early 2025 alongside information on any changes to the submission of reports and access to new schemas for GB reporting. Please continue to check Medical devices: post-market surveillance and the MORE portal for updates on timelines for new forms and access to key submission resources.
Guidance: Post-market surveillance requirements
Summary tables
Supplementary guidance on a manufacturer’s vigilance system
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Effective field safety notices – guidance for manufacturers of medical devices (website update)
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Examples of incidents which should be reported under the vigilance system
Periodic safety update reports
Device-specific vigilance guidance
Additional information
Updates to this page
Published 26 January 2015Last updated 15 January 2025 + show all updates
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Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
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Guidance updated to reflect the latest information regarding the MORE portal.
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Guidance updated.
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Added link to 'Guidance: Reporting adverse incidents involving Software as a Medical Device under the vigilance system'
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Information and links to the MORE Submissions guidance and MORE production API guidance have been added.
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Updated changes to the Incident reporting system
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Recording added for webinar 'Changes to Submitting Adverse Incidents to Medical Devices to the MHRA'
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Detailing changes to the Incident reporting system in the section 'Changes to the Incident reporting system'
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This page has been updated due to the end of the Brexit transition period.
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New document for European Commission's guidance on reporting incidents with cardiac implantable electronic devices
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Added a new document - Effective field safety notices (FSNs): guidance for manufacturers of medical devices
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New information about upcoming MDR and IVDR regulations added to the page.
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Added a link to new guidance on medical devices regulation in a no deal scenario.
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Further guidance on producing and distributing effective field safety notices has been added.
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Link to European Commissions detailed guidance updated
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First published.