The Medicines and Healthcare products Regulatory Agency (MHRA), has published a regulatory ‘roadmap’, pointing the way ahead for new measures to support safe access to medical technology including AI and diagnostics.
The new document provides an update on the intended timelines to implement the future core regulations, as outlined in the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE marked devices placed on the Great Britain market which were put in place in 2023.
In the new document, Roadmap towards the future regulatory framework for medical devices, a clear path is set out for the development of new and robust regulations for medical devices in the UK. The new regulations will put patient safety first and help to ensure that patients continue to have access without delay to the devices they need, whilst enhancing the UK’s position as a world-leading environment for medical technology innovators. It will enhance the UK’s ability to benefit from rapidly advancing medical technology, offering significant new opportunities for patients and healthcare.
Transformative technologies such as new implantable devices, healthcare AI and software, and diagnostics for early detection and prevention of disease, all demand a new regulatory framework.
The MHRA’s roadmap sets out a route to deliver enabling regulation via a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025.
The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.
Dr Laura Squire, the MHRA’s Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access, said: “Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery. We are therefore delighted to begin this new year by setting out a comprehensive plan for significant improvements to the regulatory framework for medical devices over the next two years.
The new framework will strengthen the MHRA’s ability to keep patients safe, while at the same time contributing to an environment which encourages the launch of the most innovative healthcare products that make a real difference to the public’s health. The roadmap sets out how we will work with stakeholders including patients as the process moves forward, giving early sight of what is to come and giving us feedback about the guidance they will need, to ensure the successful implementation of these wide-ranging UK reforms.
Helen Dent, Interim CEO, BIVDA, said: “BIVDA welcomes this approach by the MHRA to charting the roadmap for new UK medical device regulations. Patient safety and accessibility are essential, and this proposed timetable of measures reflects a positive step towards achieving these goals. We look forward to continuing to collaborate closely with the MHRA, industry stakeholders and our members to ensure the successful implementation of these regulations.”
