The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance today, 29 July 2026, clarifying how existing medical device law applies to ambient voice technology (AVT) products in Great Britain. This guidance was developed in partnership with NHS England (NHSE).
AVT products, also known as AI scribes, are increasingly used in the NHS to record and summarise conversations between clinicians and patients. This aims to reduce administrative tasks and support clinical documentation.
The new guidance confirms that AVT products intended solely for transcription, summarising clinical conversations, drafting letters, or suggesting clinical codes for clinician review are not regulated as medical devices. However, AVT products designed to support diagnosis, treatment, or prevention, or that automate actions without clinician review, are regulated as medical devices and must meet safety and performance requirements.
Lawrence Tallon, Chief Executive Officer of the MHRA, stated that the guidance provides clarity on the regulatory status of these technologies. Rob Thompson, Chief Digital, Data and Technology Officer at NHS England, noted that AI notetaking tools show promise in reducing administrative burdens and freeing up time for patient care.
The guidance does not change existing law but clarifies how the MHRA applies current medical device regulations to this technology. Clinicians remain responsible for reviewing and verifying AI-generated outputs before they are used in patient care.