Software and AI as a Medical Device Change Programme - Roadmap
Software (including Artificial Intelligence (AI)) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices. Last year, the MHRA announced the Software and AI as a Medical Device Change Programme
Software and AI as a Medical Device Change Programme - Roadmap
Introduction
Software (including Artificial Intelligence (AI)) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices. Last year, the MHRA announced the Software and AI as a Medical Device Change Programme, a programme of work to ensure regulatory requirements for software and AI are clear and patients are protected. This Programme builds upon wider reforms for medical devices as a whole detailed in the Government response to consultation on the future regulation of medical devices in the United Kingdom. Set out below is further information on each work package of the Change Programme, including deliverables to meet each set of broad objectives, and further information on how the broad Change Programme will be implemented.
The Change Programme will deliver bold steps to provide a regulatory framework that provides a high degree of protection for patients and public, but also makes sure that the UK is recognised globally as a home of responsible innovation for medical device software looking towards a global market. Broadly, to achieve this aim, we will focus on ensuring that:
A. The requirements for software and AI as a medical device provide assurance that these devices are acceptably safe and function as intended, thereby protecting patients and public.
B. The requirements for manufacturers are clear, supported by both clarificatory guidance and streamlined processes that work for software, as well as bolstered with the tools to demonstrate compliance, for instance, via the designation of standards.
C. The friction is taken out of the market by working with key partners such as the National Institute for Health and Care Excellence (NICE) and NHS England to align domestically, de-duplicate, and combine requirements, ultimately providing a joined-up offer for digital health within the UK. Internationally, we will work with other regulators both bilaterally, and multilaterally through the International Medical Device Regulators Forum (IMDRF) to strengthen international convergence and consensus on software and AI products.
This programme includes eleven work packages across two workstreams. The first stream contains eight work packages to make key reforms across the software as a medical device (SaMD) lifecycle, the second stream has three work packages and considers the challenges that AI as a medical device (AIaMD) can pose over and above classically programmed software.