Software and AI as a medical device: Roadmap published

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published a roadmap for its ‘Software and AI as Medical Device Transformation Programme’. As Walker Morris Regulatory & Compliance Specialist Claire Burrows explains, this builds on wider reforms in the pipeline.

The future of medical device regulation in the UK – where are we now?

The MHRA has consulted on the new post-Brexit regulatory framework for medical devices in 2021. 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 future medical device regulations to 12 months. They are intended to enter into force by July 2024.

What about software and AI as a medical tool?

Chapter 10 of the MHRA’s Consultation discusses software including AI as a medical device (‘AIaMD’) and software as a medical device (‘SaMD’). SaMD is both standalone software and software included in a wider range of hardware, including AIaMD.

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In its consultative response; In recent years, the market share of software and AI as a medical tool; The growing importance and complexity of public health; The current regulations contain a few provisions specifically aimed at regulating this. However, the government has made it clear that most of the changes needed in this area will be in 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 Software and AI as a Medical Device Change Program last year. This work plan builds on the wider reforms detailed in the consultation. It will “deliver bold steps to provide a regulatory framework that provides high protections for patients and the public, but ensures the UK is globally recognized as the home of responsible innovation for medical device software seeking global markets”.

Road map

The program consists of 11 work packages in two workplaces. The first consists of eight work packages to make key reforms throughout the SaMD life cycle. These include: competence; classification; premarket requirements; postal market; and cyber-secure medical devices. The second consists of three work packages, and AIaMD considers challenges that may arise beyond classically programmed software. These are: strictness; interpretability; and flexibility.

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For each work package; A roadmap describes: the problem the package seeks to solve; Objectives that can solve that problem; and specific deliverables that meet objectives. Work Package 6; 7 and 8 do not specify them to be allocated separately. Their contents are absorbed into the broader deliverables described.

Importantly, The MHRA says it is sensitive to the fact that regulatory innovation that departs from international consensus can create an additional burden on the market. We aim to drive international consensus forward, collaborating with others to accelerate regulatory innovation and harmonization in this area.

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The MHRA also works closely with the British Standards Institute (BSI) to ensure there are broad standards in place for manufacturers to meet regulatory requirements.

What will happen next?

The MHRA will announce plans for patient/public and industry engagement to support the work programme. Most deliverables will first be published as drafts for wider comment and input before publication.

Deliverables will be published in batches. The first drafts for the first part are intended to be published before the end of the year. The first part of the agenda includes: regulatory guidance on creating an intended purpose in the context of SaMD; Adverse event signal detection process review for SaMD; Regulatory guidance on good machine learning practices for mapping medical device development; A Best Practice Guide to AIaMD for All. Guiding Principles on Adaptability and Change Management in AIaMD.

We will continue to monitor and report on developments.


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