New legislation will introduce clearer and risk-proportionate requirements that improve the safety of medical devices across Great Britain and provide certainty for manufacturers ahead of introducing the wider future regulatory regime.
The Post-market Surveillance (PMS) Statutory instrument (SI) laid in Parliament on 21 October is the first major update to the framework of medical device regulations in Great Britain, led by the Medicines and Healthcare products Regulatory Agency (MHRA).
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.
Since January 2021 all medical devices have been required to be registered with the MHRA before they can be placed on the market in Great Britain a step-change in the Agency’s oversight of medical devices, allowing it to take more rapid action where safety concerns are identified.
By introducing clear, risk-proportionate requirements, the new legislation will build on measures already introduced to improve patient safety, facilitating greater traceability of incidents and reporting trends.
Laura Squire, MedTech Regulatory Reform Lead and Chief Officer at the MHRA, said: “Patient safety is our priority, and these new measures are expected to further reduce adverse incidents by ensuring manufacturers identify and address issues earlier and reduce the time for corrective actions to be taken.
“While the new legislation is focused on patient safety, it also benefits innovation and growth of the sector, with the collection of real-world data helping manufacturers to further improve existing products. This legislation reflects the Government’s wider priority of improving patient safety and is the first part of the new regulatory framework coming in for medical devices.’’
This regulation also ensures that we the UK has a strong foundation for patient safety in place before MHRA brings 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. The MHRA is committed to delivering a framework of regulatory reform that encourages innovation and growth in life sciences and which, in turn, brings huge benefits to patients.
The SI proposes a six-month implementation period once Parliamentary processes have been concluded. This regulation could, therefore, become law in summer 2025.
Another SI laid in Parliament on 21 October, will provide a new regulatory framework meaning that medicines with a very short shelf life and highly personalised medicines can more easily be made in or near a hospital setting and can get to the patients who need them safely and much more quickly. This novel UK regulatory framework will transform patient treatment by enabling the safe development of innovative, personalised products such as cell or gene therapy that need to be manufactured close to the individual patient.
- The draft statutory instrument, explanatory memorandum and impact assessment are available online - The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024