The guidance comes ahead of new regulations that will introduce clearer and more risk-proportionate requirements that improve the safety of medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a suite of guidance to help medical device manufacturers understand and prepare for new post-market surveillance (PMS) regulation for medical devices in the UK which will come into force in mid-June.
Key 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.
“The new post-market surveillance regulations will provide us with more safety information on medical devices in use in Britain, allowing us to act swiftly when needed to reduce potential harm,” said Laura Squire, medtech regulatory reform lead and chief officer at the MHRA.
Wider reform
These new regulations are part of wider regulatory reform and will introduce clearer and more risk-proportionate requirements that improve the safety of medical devices across the country.
In 2021, the MHRA consulted on the future regulation of medical devices. Responses to the consultation were strongly supportive of introducing clearer and more robust requirements to improve patient and public safety and called for closer alignment with international approaches.
The new regulations will apply to medical devices, including in vitro diagnostic (IVD) devices and active implantable medical devices.
The regulation comes into effect on 16 June.
