On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”).  The AVT Guidance is intended to clarify (and essentially overrule) a decision by NHS England that AVTs that summarize interactions between patients and healthcare professionals (“HCPs”) are medical devices. 

AVTs are “AI-powered tools that automatically capture and convert spoken words into text and/or other outputs.”  In a healthcare setting, such products can be used to transcribe consultations between patients and HCPs, and produce outputs including summaries of such interactions or other clinical correspondence arising from the consultation (e.g., referral letters). 

In April 2025, NHS England issued guidance suggesting that ambient scribing products in healthcare settings that use generative AI for further processing, such as summarizing the transcribed content, would be treated as high functionality and would therefore likely qualify as a medical device.  This was followed by a “priority notification” from NHS England’s Chief Clinical Information Officer that stated that any ambient scribing software that performs summarization in the healthcare setting must be regulated as at least a Class I medical device. 

In the AVT Guidance (which applies to AVTs placed on the market/put into service in Great Britain), the MHRA clarifies that summarization alone is not sufficient to trigger medical device requirements, and confirms that AVTs must have a “medical purpose” to fall within the definition of a medical device.