The government is putting patient safety first as it sets out the path ahead for new regulations for innovative medical devices like AI and early diagnostic equipment.
The Medicines and Healthcare products Regulatory Agency (MHRA) say the new roadmap will ensure NHS patients have timely access to technology while also securing the UK’s position as a world leader for med tech innovators.
Improvements to the regulatory framework for medical devices will be made over the next two years, with “priority measures” to patient safety set for this year.
“Today’s exciting medical technology advances offer important new opportunities for patient care and improvements to healthcare delivery.”
The MHRA’s Dr Laura Squire continued: “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.”
The planned regulations will also help the UK align with international partners, as a result of more patient-minded and proportionate requirements for medical devices that are responsive to technological advances.
The Association of British HealthTech Industries’ chief executive, Peter Ellingworth, said: “International recognition will ensure that UK patients maintain access to safe and effective health tech, 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.”
Helen Dent, the interim chief executive at the British In Vitro Diagnostics Association, added: “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.”
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