Ambient voice technology regulation: techUK position statement

14 Aug 2026 11:36 AM

On 29 July 2026, the Medicines and Healthcare Products Regulatory Agency (MHRA) published new guidance, developed jointly with NHS England, setting out how existing medical device law applies to ambient voice technology (AVT) used across health and care settings in Great Britain. techUK has followed this issue closely and welcomes the clarity the guidance provides.

What is AVT, and why does it matter?

Ambient voice technology is used increasingly across the NHS to record and summarise conversations between clinicians and patients, cutting down time spent on administrative tasks and supporting clinical documentation. As adoption has grown, so has the question of where these tools sit under medical device law: a question with real consequences for suppliers, NHS organisations and, ultimately, patients.

What the guidance says

The MHRA's guidance draws a clear regulatory line:

• AVT products intended solely for transcription, summarising clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices under the current framework.
• AVT products intended to support diagnosis, treatment or prevention, or that take automated action (such as placing orders) without clinician review, remain regulated as medical devices and must meet the relevant safety and performance requirements.

Clinicians remain responsible for reviewing and verifying AI-generated transcripts, summaries and other outputs before they are used in patient care, a responsibility the guidance does not change. NHS boards and executive teams are also asked to assure themselves that AVT deployment is backed by proper clinical oversight, local governance, staff training and procurement processes, and that any change to a product's functionality that might alter its regulatory status is identified and reviewed.

Importantly, the guidance does not change the underlying law. it clarifies how the MHRA applies existing medical device regulation to a fast-growing category of technology, and it reflects the direction of travel 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.

techUK's position

We support the work of the MHRA and the MHRA AI Commission and look forward to receiving its recommendations later in the summer. We are especially supportive of the direction of travel towards a clear, risk-proportionate framework for AI in health and care.

The approach taken by the MHRA reflects a principle that techUK has long advocated for: that regulation should be proportionate to risk, and that AI tools which are not being used for clinical use do not need to be regulated as medical devices.

Regarding Ambient Voice Technology (AVT) specifically, most AVTs currently on the market are administrative tools, they help clinicians with documentation and record-keeping, and do not diagnose, treat, or make clinical decisions. Applying medical device classification to these tools was always a cautionary, interim position, and the MHRA should be commended for keeping its regulatory approach under review as the evidence base and market have matured.

Critically, any AVT that does claim a medical intended purpose such as generating diagnoses or treatment recommendations will continue to be regulated as a medical device under the MHRA's existing framework. The safeguards that matter most remain firmly in place.

It is also worth noting that NHS trusts and ICBs retain the ability to set their own procurement requirements. Those that wish to specify medical device classification as a condition of purchase remain entirely free to do so. This guidance does not prevent commissioners from applying these standards where they judge it appropriate.

We have long advocated for regulation that is proportionate, coherent, and supportive of responsible innovation. A framework that imposes identical requirements on an AI scribe and a diagnostic imaging algorithm is neither of those things. This update moves us closer to a regulatory environment that is fit for purpose one that protects patients where risk genuinely exists, while removing unnecessary friction for innovations that do not pose clinical risk.

We look forward to the forthcoming report from the MHRA's AI Commission and will continue to work constructively with the MHRA and other regulators to support safe, effective adoption of AI across health and care.

What comes next

The MHRA has said it will continue working with NHS England and other partners to develop further guidance as the technology and the needs of the health system evolve. techUK will continue to engage closely with the MHRA and the National Commission into the Regulation of AI in Healthcare as its recommendations are published later in the summer and will keep members updated as the wider regulatory framework for AI in health and care takes shape.

For more information on techUK's work in this area, please contact Rachel Kennedy, Head of Health and Social Care, rachel.kennedy@techuk.org.