The MHRA has clarified when AI scribes used by the NHS are regulated as medical devices under existing law in Great Britain.
The guidance covers ambient voice technology, which records and summarises conversations between clinicians and patients to support clinical documentation.
It was developed by the MHRA in close partnership with NHS England.
Lawrence Tallon, chief executive of the 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.”
The technology is increasingly being used across the NHS to reduce the time clinicians spend on administrative work.
Tools intended solely to transcribe or summarise clinical conversations, draft letters or suggest clinical codes for a clinician to review are not regulated as medical devices under the current framework.
NHS England has issued separate guidance to help organisations introduce ambient scribing products safely in health and care settings in England.
Products intended to support diagnosis, treatment or disease prevention are regulated as medical devices and must meet the relevant safety and performance requirements.
This also applies to systems that take automated actions, such as placing orders, without a clinician reviewing them first.
The guidance does not change the law. It explains how existing medical device regulations apply to the technology.
The MHRA said it was 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 future regulation.
Rob Thompson, chief digital, data and technology officer at NHS England, said: “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.
NHS boards and executive teams are asked to ensure that deployments have appropriate clinical oversight, local governance, staff training and procurement processes.
They should also identify and review changes to a product’s functions that could affect whether it is regulated as a medical device.
The MHRA said it would continue working with NHS England and other partners on further guidance as the technology and the needs of the health system develop.
Haris Shuaib, NHS consultant clinical scientist and founder and chief executive of Newton’s Tree, said: “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 of THIS Institute at the University of Cambridge, added: “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.”
