Software and AI as a Medical Tool: Roadmap Published

Software and AI as a Medical Tool: Roadmap Published

The Medicines and Healthcare Products Regulatory Agency (MHRA) recently published a roadmap for its ‘Software and AI as Medical Device Change Programme’. This builds on broader improvements in the pipeline, explains Claire Burroughs, Walker Morris Regulatory and Compliance Specialist.

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

The MHRA will consult on a 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 mentioned that the MHRA has now extended the implementation of future medical device regulations by 12 months. It is targeted to be implemented by July 2024.

What about software and AI as medical tools?

Chapter 10 of the MHRA’s consultation deals with software as a medical device (‘AIAMD’), including AI as a medical device (‘SAMD’). SAMD is standalone software and software that is included in the wider hardware includes AIMD.

In its consultation response, the government noted that software and AI as a medical tool have grown in market share, public health importance and complexity in recent years; And the present rules contain certain provisions specifically aimed at regulating it. However, the government has made it clear that much of the change needed in this area is likely to 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 last year announced Software and AI as part of the Medical Device Transformation programme. This action program is based on comprehensive reforms detailed in counseling. It will take “bold steps to provide a regulatory framework that delivers a high level of protection for patients and the public, but also ensures the UK continues to be recognized as the home of responsible innovation for medical device software looking to the global market”. be recognized globally”.


The program consists of 11 work packages in two workstreams. The first includes eight work packages to make major improvements to the SaMD lifecycle. These include: qualification; classification; premarket requirements; post market; and cyber secure medical devices. The second has three work packages and considers the challenges that AIaMD may present over and above classically programmed software. These are: Rigidity; interpretability; and compatibility.

For each work package, the roadmap describes: the problem the package seeks to solve; objectives that break down that problem; and specific deliverables that meet the ambition. Work Packages 6, 7 and 8 do not have individual deliverables assigned. Their content has been incorporated into the specified broad deliverables.

Importantly, the MHRA says it is sensitive to the fact that regulatory innovations that depart from international consensus can create additional burdens for the market. It intends to advance international consensus while working with others to accelerate regulatory innovation and harmonization in this area.

The MHRA is also working closely with the British Standards Institution (BSI) to ensure that there is a comprehensive set of standards in place to help manufacturers meet regulatory requirements.

what happens next?

The MHRA will announce plans for patient/public and industry engagement to support the action programme; And most deliverables will be released first in draft form for extensive comment and input before being published.

Will be published in deliverable installments. The first draft of the first tranche is intended to be published before the end of the year. The first tranche includes: regulatory guidance on formulating an intended objective in the context of SAMD; Review of Adverse Event Signal Detection Process for SAMD; Regulatory Guidance on Good Machine Learning Practices for Mapping Medical Device Development; Best practice guidance on AIAMD for all; and Guiding Principles on Adaptability and Change Management at AIAMD.

We will continue to monitor and report on developments.

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