MHRA Provides Clarity on Regulatory Status of Ambient Voice Technologies in NHS

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 29 July 2026, released guidance that has been developed in close collaboration with NHS England (NHSE). This guidance clarifies the application of existing medical device legislation to ambient voice technology (AVT) products used within health and care settings across Great Britain.

This initiative supports the NHS’s overarching goal of becoming the most AI-enabled health system globally, providing developers, suppliers, and NHS organisations with the necessary clarity to adopt AVT tools confidently and safely.

Understanding Ambient Voice Technology in the NHS

AVT products, commonly known as AI scribes, are increasingly utilised within the NHS to document and summarise conversations between clinicians and patients. This technology helps alleviate administrative burdens, allowing healthcare professionals to dedicate more time to clinical duties.

The guidance clarifies that AVT products designed solely for transcription, summarisation of clinical discussions, drafting letters, or suggesting clinical codes for clinician review are not classified as regulated medical devices under current legislation. Users of such AVT products are encouraged to consider the necessary information and practices to ensure their safe implementation. NHSE has also provided guidance on the use of AVT products in health and care environments, assisting those who are adopting ambient scribing technologies in England.

However, AVT products that assist in diagnosis, treatment, or prevention, or that take automated actions—such as placing orders without clinician oversight—are classified as medical devices and must comply with the relevant safety and performance standards.

Clarifying Regulatory Frameworks for Emerging Technologies

This guidance does not modify existing laws but rather elucidates how the MHRA applies current medical device regulations to this rapidly evolving technology. The guidance was developed with contributions from NHS clinicians, technologists, and advocates for patient safety. It also aligns with the objectives of the National Commission into the Regulation of AI in Healthcare, which is collaborating with the MHRA, NHS England, and other stakeholders to shape the future regulatory landscape for AI in health.

Lawrence Tallon, Chief Executive Officer of the MHRA, remarked on the significance of this guidance, stating, “This is a crucial advancement for the secure and assured integration of AI within healthcare environments. NHS organisations, suppliers, and clinicians have sought clarity regarding the regulatory boundaries surrounding this rapidly expanding technology, and this guidance aims to provide that clarity.”

He further explained that by delineating which functionalities of ambient voice technologies are classified as medical devices and which are not, the guidance seeks to eliminate ambiguity. This will facilitate the quicker adoption of lower-risk tools that significantly alleviate administrative tasks, enabling clinicians to concentrate more on patient care.

Commitment to Safe Implementation and Oversight

Rob Thompson, Chief Digital, Data and Technology Officer at NHS England, highlighted the promise of AI notetaking tools in lessening the administrative workload on frontline staff, thereby allowing for increased patient interaction. He stressed the necessity for proper safeguards during the adoption of such technologies, stating, “We’ve collaborated closely with the MHRA to formulate this guidance, which clarifies how NHS organisations should evaluate, introduce, and manage these tools.”

Clinicians remain responsible for reviewing and validating AI-generated transcripts, summaries, and other outputs before incorporating them into patient care, a responsibility that remains unchanged by the new guidance.

NHS boards and executive teams are encouraged to ensure that the deployment of AVT is supported by appropriate clinical oversight, local governance, staff training, and procurement processes. They must also identify and review any changes in a product’s functionality that might affect its regulatory status.

Future Directions for AI in Healthcare

The MHRA is committed to continuing its collaboration with NHS England and other partners to further develop guidance as technology and healthcare needs evolve. Haris Shuaib, NHS Consultant Clinical Scientist and Founder & CEO of Newton’s Tree, emphasised that for AI to make a meaningful impact in healthcare, organisations require clear regulations and the confidence to innovate and manage their governance processes. He noted that this guidance is a significant step forward, providing the practical clarity needed for the NHS to adopt ambient voice technologies effectively and consistently.

Professor Mary Dixon-Woods, Director of the THIS Institute at the University of Cambridge, echoed the importance of regulatory clarity in a rapidly advancing field like AI. She stated, “This timely guidance from the MHRA is invaluable in clarifying when Ambient Voice Technologies are deemed medical devices and when they are not, while also underscoring the essential roles of clinicians and NHS leadership teams in the deployment of these technologies in patient care.”

About the MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) oversees the regulation of all medicines and medical devices in the UK, ensuring their efficacy and safety. All its operations are grounded in robust, evidence-based assessments to guarantee that the benefits outweigh any associated risks.

The MHRA is an executive agency of the Department of Health and Social Care.

For media inquiries, please contact newscentre@mhra.gov.uk or call 020 3080 7651.