MHRA clarifies regulatory status of ambient voice technologies used in the NHS - GOV.UK

The guidance states that clinicians remain responsible for reviewing and verifying AI-generated outputs before incorporating them into patient care. The MHRA emphasised that ambient voice technologies, which automatically transcribe and summarise patient consultations, are classified as medical devices and must comply with relevant regulatory requirements.

The clarification comes as NHS trusts increasingly deploy ambient voice tools to reduce administrative burden on clinicians. The MHRA noted that while these technologies can assist with documentation, they do not replace clinical judgment. The guidance applies to all ambient voice products used within the NHS, whether developed in-house or procured from third-party vendors.

The MHRA's statement aligns with its broader regulatory approach to software as a medical device, which requires risk classification and conformity assessment for AI products with clinical applications. The MHRA indicated it would continue to monitor the technology and update guidance as needed.