MHRA issues transparency guidance for machine learning medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) has published guiding principles for machine learning medical devices focusing on transparency.

The guidance on the transparency of machine learning medical devices, published on 13 June 2024, was jointly established by MHRA, the US Food and Drug Administration (FDA) and Health Canada to ensure that information is communicated clearly and is relevant to its intended audience.

It builds on 10 guiding principles for good learning practice, published by the three organisations in 2021.

According to the MHRA guidance: “These guiding principles are intended as considerations when adopting and advancing good transparency practices.

“Continued engagement on this topic can help inform the collaborative development, implementation and iteration of good transparency practices and consensus standards in this rapidly evolving field.”

The guiding principles consider transparency around the relevant audiences and motivation for using a medical device.

This includes who is using a device, who is receiving healthcare with the device and any other parties who may make decisions about the device to support patient outcomes.

The guidance also covers transparency around the type of information needed, placement of information, timing of information and the methods used to support transparency.

This may include information about a device’s medical purpose and function, the conditions it can be used for, as well as summaries of clinical studies.

The guidance explores how the software user interface can be optimised to support transparency, allowing information to be personalised, adaptive and reciprocal.

It also advises that information needs should be considered throughout each stage of the product lifecycle and recommends targeted information such as on-screen instructions or warnings as new information is discovered.

In January 2024, the MHRA published its regulatory roadmap for the development of medical devices, which focuses on protecting patients’ safety, while enabling all UK patients to have access to innovative medical technologies.

This was followed by the publication of the MHRA’s strategic approach to AI on 30 April 2024.