The Medicines and Healthcare products Regulatory Agency (MHRA) has today 29 July 2026 published guidance, developed in close partnership with NHS England (NHSE), clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain.
The guidance will support the wider ambition for the NHS to become the most AI-enabled health system in the world, giving developers, suppliers and NHS organisations the clarity needed to adopt AVT tools safely and with confidence.
AVT products, often referred to as AI scribes, are increasingly used across the NHS to record and summarise conversations between clinicians and patients, reducing time spent on administrative tasks and supporting clinical documentation.
The new guidance confirms that those AVT products that are intended solely for transcription, summarising of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices under the current framework. Users of such AVT products should carefully consider what information and practices are needed to ensure safe deployment. NHSE has issued guidance on the use of AVT products in health and care settings to assist those adopting ambient scribing products in England.
AVT products intended to support diagnosis, treatment or prevention, or that take automated action such as placing orders without clinician review, are regulated as medical devices and must meet the relevant safety and performance requirements.
This guidance does not change the law. It sets out how the MHRA applies existing medical device regulations to this fast-growing technology and has been developed with input from NHS clinicians, technologists and patient safety advocates. It also reflects the direction of the National Commission into the Regulation of AI in Healthcare, which is working with the MHRA, NHS England and other partners on the future regulatory framework for AI in health.
Lawrence Tallon, Chief Executive Officer, MHRA said:
“This guidance is an important step forward for the safe and confident adoption of AI in healthcare settings.
“NHS organisations, suppliers and clinicians have been asking for clarity on where the regulatory line sits for this high-growth and high-potential technology, and this guidance aims to provide it.
“We are setting out which functions of ambient voice technologies are deemed medical devices and which are not in order to remove ambiguity. This will help to unlock faster uptake of lower risk tools that significantly reduce the burden of administrative work, such as transcribing or summarising conversations, in turn, giving clinicians more quality time focusing on patients.
“Crucially, where a product supports diagnosis or treatment, regulatory protections will still apply.”
Rob Thompson, Chief Digital, Data and Technology Officer, NHS England
Excerpt from the official page. The original is authoritative. Continue reading at UK MHRA ↗