UK MHRA Issues Guidance Clarifying Regulation of AI Clinical Scribe Tools

The Medicines and Healthcare products Regulatory Agency (MHRA), working with NHS England, has released guidance that interprets existing medical‑device law for ambient voice technology (AVT) used in health and care settings in Great Britain. The guidance states that AVT products intended solely for transcription, summarising clinical conversations, drafting letters or suggesting clinical codes for clinician review are **not** classified as medical devices, allowing faster, lower‑risk adoption. By contrast, AVT tools that support diagnosis, treatment, disease prevention, or that can take automated actions without clinician oversight remain subject to medical‑device regulations and must meet safety and performance standards.

The move aims to reduce the administrative burden on NHS clinicians and advance the ambition of making the NHS the most AI‑enabled health system worldwide. Lawrence Tallon, CEO of MHRA, said the guidance "provides clarity on where the regulatory line sits for this high‑growth technology". Rob Thompson, Chief Digital, Data and Technology Officer at NHS England, highlighted that AI notetaking tools are already showing promise in freeing staff time, but must be adopted with appropriate safeguards.