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Software and AI as a medical device: Roadmap published

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The Medicines & Healthcare Products Regulatory Agency (MHRA) recently released a roadmap for “Software and AI as a Medical Device Modification Program”. As Walker Morris regulatory and compliance expert Claire Burroughs explains, this builds on a broader reform of the pipeline.

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

In 2021, the MHRA will discuss a new post-Brexit regulatory framework for medical devices. The government’s response was announced in June this year. In a recent briefing, the MHRA explained that it has extended the implementation of future medical device regulations by 12 months. It aims to enter into force by July 2024.

What about software and AI as medical devices?

Chapter 10 of the MHRA Consultation deals with Software as a Medical Device (“SaMD”), including AI as a Medical Device (“AIaMD”). SaMD is stand-alone software, software included in the wider hardware that includes AIaMD.

In its response to the consultation, the government said the market share, public health importance and complexity of software and AI as medical devices have increased in recent years. Current regulations contain few provisions specifically aimed at regulating it. However, the government has made it clear that most of the changes needed in this area will likely be in the form of guidance rather than legislation. Clarify what you mean.

MHRA last year announced software and AI as a medical device modification program. This work program builds on the broader reforms detailed in the consultations. It “offers bold steps to provide a regulatory framework that offers a high degree of protection to patients and the general public, as well as making the UK a home for responsible innovation in medical device software with an eye on global markets. to be recognized worldwide.”


The program consists of 11 work packages across two workstreams. The first package contains eight work packages for major reforms across the SaMD lifecycle. These include: Classification; pre-market requirements; post-market; cyber-secured medical devices. The second, consisting of three work packages, explores the challenges that AIaMD can pose in addition to software programmed with traditional programs. These are: interpretability; and adaptability.

For each work package, the roadmap describes: The problem the package is trying to address. purpose of overcoming the problem. And tangible deliverables that satisfy the ambition. Work packages 6, 7, and 8 have not been assigned separate deliverables. Their content is absorbed into the broader work outlined.

Importantly, the MHRA says it is sensitive to the fact that regulatory innovations that deviate from international consensus may create additional burdens on the market. It is intended to promote international consensus and collaborate with other countries to accelerate regulatory innovation and harmonization in this area.

MHRA also works closely with the British Standards Institution (BSI) to ensure that they have a broad set of standards to help manufacturers meet their regulatory requirements.

what happens next?

MHRA will announce plans for patient/public and industry engagement to support the work programme. Also, most deliverables are first released as drafts for broad comment and input before publication.

Artifacts are published in tranches. A first draft of the first tranche is expected to be published by the end of the year. Here is the first tranche: Regulatory guidance for creating intended purposes in the context of SaMD. A review of the SaMD adverse event signal detection process. Regulatory guidance on good machine learning practices for medical device development mapping. Best practice guidance on AIaMD for everyone. Fundamental principles of adaptability and change management in AIaMD.

We will continue to monitor and report on trends.

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