The Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK provides a comprehensive framework for the regulation of SaMD. It includes considerations such as clinical evaluation, risk management, post-market surveillance, and more. As language models increasingly assist healthcare professionals in decision-making processes, it becomes essential to establish appropriate guidelines and regulations to govern their use. When such products approach the market in the United Kingdom, they will be regulated by the Medical Device Regulation 2002 (as modified), MHRA
Using LLMs in healthcare
Large Language Models that are exclusively intended for non-medical uses and whose creators make no mention of the software being used for medical reasons are unlikely to be considered medical devices.LLMs, on the other hand, are likely to be considered medical devices if they were created for, or adapted, modified, or focused toward, primarily medical uses. It is also possible that a product qualifies as a medical device if a developer states that their LLM may be used for a medicinal purpose.
Developers of these goods can find information on how to determine if software products qualify as medical devices and their suitable classification in our accompanying Medical Devices: Software Applications (Apps) Guidance.
It is critical to emphasize that the necessity for acceptable clinical evidence and establishing that the device functions as intended under typical conditions of usage is fundamental to medical device regulation. Additionally, many open-source LLMs are likely to be classified as software of unknown origin (SOUP), where they are later altered or employed as a component of a larger medical device by a third party
LLM-based medical devices must comply with medical device requirements to be safe and effective, and regulators are excited to watch them develop further.
The MHRA is still considering how to best ensure LLMs, but every medical device must have proof that it is safe under normal circumstances of use and functions as intended, as well as meet with other applicable medical device regulatory standards.
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Source: MHRA Notifications
