The Medicines and Healthcare products Regulatory Agency has published guidance, developed in close partnership with NHS England, clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain.
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
"AI notetaking tools are already showing real promise in reducing the administrative burden on frontline staff and freeing up more time for patient care, but the technology must be adopted with the right safeguards in place.
"We've worked closely with the Medicines and Healthcare products Regulatory Agency to develop this new guidance, which provides clarity for NHS organisations on how these tools should be assessed, introduced and managed.
"We'll now begin rolling out the technology across the NHS safely, consistently and at scale so staff can spend more of their time where it matters most - with patients."
Clinicians remain responsible for reviewing and verifying AI generated transcripts, summaries and other outputs before they are used in patient care. This responsibility is unchanged by the guidance.
NHS boards and executive teams are asked to assure themselves that AVT deployment is supported by appropriate clinical oversight, local governance, staff training and procurement processes, and that any change in a product's functionality that may alter its regulatory status is identified and reviewed.
The MHRA will continue to work with NHS England and other partners to develop further guidance as the technology and the needs of the health system evolve.
Haris Shuaib, NHS Consultant Clinical Scientist, Founder & CEO, Newton's Tree
"For AI to deliver real impact in healthcare, organisations need clear rules and confidence to innovate and manage their own governance processes. This guidance is an important step forward, providing practical clarity that will help the NHS adopt ambient voice technologies more consistently and at greater scale."
"By removing uncertainty around lower-risk uses of these tools, the MHRA is helping unlock the potential for these technologies to improve patient care and enable operational efficiency."
Professor Mary Dixon-Woods, Director, THIS Institute, University of Cambridge
"In a field moving as fast as AI, regulatory clarity is crucial. This timely new guidance from MHRA is very helpful in distinguishing when Ambient Voice Technologies are classed as a medical device and when they are not. It also highlights the important roles of clinicians and NHS leadership teams when deploying these technologies in patient care."
Notes
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
