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 16 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.
These new regulations are part of wider regulatory reform and will introduce clearer and more risk-proportionate PMS requirements that improve the safety of medical devices across GB and provide certainty for manufacturers.
These new regulations will apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices, in use in GB. However the PMS requirements vary based on the risk level posed by the device to patients. The guidance will provide additional detail on these requirements to support manufacturers with their PMS activities and help to ensure their devices continue to meet appropriate standards of safety and performance.
As businesses put the new guidance into use, feedback is welcomed, and the MHRA encourages this to be provided through Trade Associations, if businesses have one, who will be working closely with the MHRA to help identify and address where additional enhancements are needed. The MHRA will then update the guidance, if necessary, prior to the regulations coming into force.
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.”
In 2021, the MHRA consulted on the ‘Future Regulation of Medical Devices in the UK’ in response to recommendations set out in the Independent Medicines and Medical Devices Safety (IMMDS) review, published in 2020.
Responses to the consultation were strongly supportive of introducing clearer and more robust PMS requirements to improve patient and public safety and called for closer alignment with international approaches.
This regulation delivers these requirements and will ensure that the MHRA has a strong foundation for patient safety in place before bringing forward future measures such as international reliance, which will allow patients to benefit more quickly from some types of medical devices that have already been approved for use in other countries.
This regulation marks a significant step forward in ensuring that medical devices used across the UK are safe, effective, and continually monitored for performance in real-world conditions, ensuring that patient safety remains at the forefront of our healthcare system.
Article published on behalf of MHRA.