Today, a clear path ahead has been 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.
This new ‘roadmap’ for new
regulations, from the Medicines and Healthcare products
Regulatory Agency (MHRA), 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.
Peter Ellingworth, Chief Executive, ABHI (Association of
British HealthTech Industries), said:
International recognition will ensure that UK patients maintain
access to safe and effective HealthTech, that is both
life-enhancing, and life-saving. Today’s publication is an
important step in this regard and can help to drive innovation
and growth into 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 fora, such as the International
Medical Device Regulators Forum and the Global Medical Technology
Alliance, to ensure successful implementation.
Helen Dent, Interim CEO, BIVDA, said:
BIVDA (British In Vitro Diagnostics Association) 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.
Edmund Proffitt, UK Med Tech Forum & BDIA (British
Dental Industry Association) said:
It is pleasing to see the MHRA set out a clear roadmap for the
future of medical devices regulation, particularly as it is so
innovative and collaborative.
Such an approach is a great step forward to enhancing the
availability of innovative and safe health technologies to
patients, as well as ensuring continuity of supply.
The visual timeline of the MHRA roadmap can be found here.
