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.
The MHRA has updated its processes and procedures to ensure that trends, patterns or signals that may reveal new risks or safety concerns are identified more efficiently. This will allow both the MHRA and the whole healthcare system to better protect patients. Updated MORE guidance has been published detailing any changes to the submission of reports. Further guidance will be made available alongside access to new schemas for GB reporting before these regulations come into force. The MHRA are working closely with industry to support adoption and smooth implementation of the new requirements. Please continue to check this page and the MORE portal for updates on timelines for new forms and access to key submission resources.
Guidance on the post-market surveillance requirements for manufacturers
Video explainer
Summary tables
Supplementary guidance on a manufacturer’s vigilance system
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Effective field safety notices – guidance for manufacturers of medical devices
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Examples of incidents which should be reported under the vigilance system
Guidance on the Manufacturers online reporting environment (MORE)
- Manufacturer’s Online Reporting Environment (MORE) guidance
- GB MIR and FSCA schema implementation guide
- Implementation of data requirements under the new Post-Marketing Surveillance regulations
- Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations
Periodic safety update reports
Device-specific vigilance guidance
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Device specific vigilance guidance: Coronary Stents and associated delivery systems
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Device specific vigilance guidance: Inferior vena cava (IVC) filters
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Device specific vigilance guidance: Cardiac Implantable Electronic Devices (CIEDs)
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Adverse incidents: in vitro diagnostic (IVD) blood glucose meters
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Reporting adverse incidents: insulin pumps and meter systems
Additional information
Updates to this page
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Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.
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Link added for 'Documentation for implementation of data requirements under the new Post-Marketing Surveillance regulations'
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Updated to provide the latest information regarding the MORE portal.
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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.