Software and AI as a medical device: published roadmap

Software and AI as a medical device: published roadmap

The Medicines and Healthcare Products Regulatory Agency (MHRA) recently released a roadmap for its “Software and AI as a Medical Device Change Agenda”. This builds on broader reforms underway, as Walker Morris regulatory and compliance expert Claire Burrows explains.

Future regulation of medical devices in the UK – where are we now?

The MHRA consulted in 2021 on a new post-Brexit regulatory framework for medical devices. The government’s response was published in June this year. In our recent briefing, we explained that the MHRA has now extended the implementation of the future medical device regulations by 12 months. It aims to bring them into force by July 2024.

What about software and AI as a medical device?

Chapter 10 of the MHRA consultation discusses Software as a Medical Device (“SaMD”), including AI as a Medical Device (“AIaMD”). SaMD is stand-alone software and software embedded in broader hardware and including AIaMD.

In its response to the consultation, the government said that software and AI as a medical device have grown in terms of market share, public health importance and complexity over the past few years; and the current regulations contain few provisions aimed specifically at regulating it. However, the government has clarified that the majority of the changes required in this area are likely to take the form of guidance rather than legislation. For example, clarifying what medical device requirements mean in the context of software and AI.

The MHRA announced the software and AI as a medical device change program last year. This work program builds on the broader reforms detailed in the consultation. It “will take bold steps to provide a regulatory framework that offers a high degree of protection for patients and the public, but also ensures that the UK is recognized globally as a home of responsible innovation for medical device software aimed at a global market”.

The roadmap

The program consists of 11 work modules spread over two work streams. The first contains eight work packages for carrying out key reforms throughout the SaMD life cycle. These include: qualification; classification; pre-market requirements; post-marketing; and cyber-secure medical devices. The second includes three work packages and considers the challenges that AIaMD can pose beyond classically programmed software. These are: rigor; interpretability; and adaptability.

For each work package, the roadmap describes: the problem the package seeks to solve; the objectives that break down this problem; and the specific deliverables that meet the ambition. Work packages 6, 7 and 8 do not have separate deliverables assigned to them. Their content has been absorbed into the larger deliverables described.

Fundamentally, the MHRA says it is sensitive to the fact that regulatory innovation that deviates from the international consensus can create an additional burden on the market. He intends to advance international consensus, working with others to accelerate regulatory innovation and harmonization in this area.

The MHRA also works closely with the British Standards Institute (BSI) to ensure there is a wide range of standards to help manufacturers meet regulatory requirements.

What happens next?

The MHRA will announce patient/public and industry engagement plans to support the work programme; and most deliverables will first be released as drafts for broader comment and input before being published.

The deliverables will be published in installments. The first drafts of the first tranche should be published before the end of the year. The first tranche includes: regulatory guidance on developing a planned target in the context of the SaMD; review of the adverse incident signal detection process for the SaMD; regulatory guidance on machine learning best practices for medical device development mapping; advice on AIaMD best practices for everyone; and guiding principles on adaptability and change management in AIaMD.

We will continue to monitor and report on developments.

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