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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鈥�16 June 2025鈥痑nd 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.听

The new set of regulations 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.听

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.听听

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.听 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听this page听and听the听听for updates on timelines for new forms and access to key submission resources.

Guidance on the post-market surveillance requirements听for manufacturer鈥檚听听

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

Summary tables听

• Table of key changes听

• Table of requirements applying to different devices听

Supplementary guidance on a manufacturer鈥檚 vigilance system听

• Effective field safety notices 鈥� guidance for manufacturers of medical devices (website update)听

• Examples of incidents which should be reported under the vigilance system听听

Guidance on the Manufacturers online reporting environment (MORE)

• Manufacturer鈥檚 Online Reporting Environment (MORE) guidance
• GB MIR and FSCA schema implementation guide
• Implementation of data requirements under the new Post-Marketing Surveillance regulations

Periodic safety update reports听

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: standardised format for periodic safety update report (PSUR)

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies听

Device-specific vigilance guidance

• Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

• Reporting adverse incidents: intraocular lenses

• Reporting adverse incidents: joint replacement implants

• Reporting adverse incidents: neurostimulators

• Breast implants: reporting adverse incidents

• Reporting adverse incidents: insulin pumps and meter systems

• Reporting adverse incidents: devices for cardiac ablation

• Reporting adverse incidents: software as a medical device