The Medicines and Healthcare products Regulatory Agency (MHRA) has published a roadmap for future regulations on medical technologies, indicating that it will cover healthcare AI, software and diagnostics.
It said the technologies – which also include new implantable devices – will help to detect and prevent diseases but require a new regulatory framework to ensure patient safety.
Its roadmap sets out a route to deliver the regulation through a series of new statutory instruments. Priority measures will be put in place this year and core elements of the new framework will be implemented next year.
MHRA said the planned regulations will also be designed to deliver greater international harmoisation, with more patient centred, proportionate requirements for medical devices that are responsive to technological advances.
Discussions, draft and guidance
Key features of the roadmap include running a series of stakeholder discussions on the core requlations through the year before a draft is published towards the end, with guidance on software and medical devices to be published in two stages: for machine learning and AI during the spring, and data driven research by late summer.
The core regulations are scheduled to be laid before Parliament early next year, hopefully to go into force in the following months.
Dr Laura Squire, MHRA’s med tech regulatory reform lead, said: “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.”
