2024-01-13 12:42:25
Today, a clear way forward has been opened to develop strong new regulations for medical devices in the UK. The new regulations will put patient safety first and help ensure patients continue to have prompt access to the devices they need, enhancing the UK’s position as a world-leading environment for medical technology innovators.
Image credit: Medicines and Healthcare products Regulatory Agency (MHRA)
This new ‘roadmap’ for new regulations, from the Medicines and Healthcare Products Regulatory Agency (MHRA), will boost the UK’s ability to benefit from rapidly advancing medical technology, offering significant new opportunities for patients and healthcare services.
Transformative technologies such as new implantable devices, artificial intelligence and software for health, and diagnostics for the early detection and prevention of disease all require a new regulatory framework.
The MHRA Roadmap sets out a route for enabling regulation through a series of new Statutory Instruments (SIs). Priority measures to protect patient safety will be implemented this year, with core elements of the new framework set to be in place until 2025.
The planned regulations are also intended to provide greater international harmonisation, with more proportionate patient-centred requirements for medical devices that respond to technological advances.
Dr Laura Squire, lead for med tech regulatory reform at the MHRA and director of health, quality and access, said:
“Today’s exciting medical technological advances offer important new opportunities for patient care and improvements in health care delivery.
“We are therefore pleased to start the new year by defining a comprehensive plan for significant improvements in the regulatory framework of medical devices over the next two years.
“The new framework will strengthen the MHRA’s ability to keep patients safe, while contributing to an environment that encourages the launch of the most innovative healthcare products that make a real difference to public health.
“The roadmap sets out how we will work with stakeholders including patients as the process progresses, giving an early view of what is to come and giving us feedback on the guidance they will need to ensure the successful implementation of these wide-ranging reforms in the UK.”
International recognition will ensure UK patients retain access to safe and effective HealthTech, which is both life-enhancing and life-saving. Today’s announcement is an important step in this regard and could help drive innovation and growth for the UK, while enabling home-grown businesses to expand their global presence.
We look forward to working with the MHRA, and maintaining our engagement through international forums, such as the International Forum of Medical Device Regulators and the Global Medical Technology Alliance, to ensure successful implementation.”
Peter Ellingworth, CEO of ABHI
Helen Dent, Interim CEO, BIVDA, said:
“BIVDA (British In Vitro Diagnostic Association) welcomes this approach by the MHRA to outline the road map for new medical device regulations in the UK. Patient safety and accessibility are essential, and the proposed schedule of measures represents a positive step toward achieving these goals.
“We look forward to continuing to work closely with the MHRA, industry stakeholders and our members to ensure the successful implementation of these regulations.”
Edmund Proffitt, UK Medical Medicine Forum and BDIA (British Dental Industries Association) said:
“It is pleasing to see the MHRA setting out a clear roadmap for the future of medical device regulation, particularly as it is so innovative and collaborative.
“Such an approach is a big step forward in increasing the availability of innovative and safe healthcare technologies for patients, as well as ensuring continuity of supply.”
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