In an effort to help safeguard patient safety, the Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled a comprehensive regulatory roadmap to support safe access to new medical technology like AI. 

The MHRA’s roadmap outlines a strategic plan to implement enabling regulations through a series of new Statutory Instruments (SIs). Priority measures focused on safeguarding patient safety are slated to be implemented this year, with core components of the regulatory framework expected to be in place by 2025.

“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,” said Peter Ellingworth, chief executive at Association of British HealthTech Industries.

The proposed framework is designed to promote internal harmonisation, more patient centred, and promote proportionate requirements for medical devices that can adapt to new technological advancements.

“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,” said Dr Laura Squire, the MHRA’s med tech regulatory reform lead and chief officer healthcare, quality and access.

The roadmap emphasises collaboration with stakeholders, including patients, throughout the process. Stakeholders will be given early insights into the upcoming changes, allowing for valuable feedback to ensure the successful implementation of these wide-ranging reforms.

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Industry leaders have welcomed the initiative, recognising the importance of international recognition for UK patients to access safe and effective healthtech.

“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,” commented Edmund Proffitt, UK Med Tech Forum & BDIA (British Dental Industry Association) 

“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,” said Helen Dent, interim CEO, BIVDA.

“We look forward to continuing to collaborate closely with the MHRA, industry stakeholders and our members to ensure the successful implementation of these regulations.”