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.
Background
The Medical Devices Regulations 2002 (“UK MDRs”) define a “medical device” by reference to the manufacturer’s intended purpose, providing that a product (including software) will be a medical device if it is “intended by the manufacturer to be used for human beings for the purpose of […] diagnosis, prevention, monitoring, treatment or alleviation of disease […].”
The NHS England guidance and priority notification introduced confusion into the UK landscape for AVTs by suggesting that summarization alone, even in the absence of a medical purpose, could cause an AVT to be a medical device. This led to a number of AVT developers obtaining Class I UKCA mark status for their AI scribes.
Updated Position
The MHRA’s AVT Guidance has essentially overruled NHS England and confirmed thatsummarization functions alone do not trigger medical device classification for ambient scribing products used in healthcare settings.
The MHRA confirms that “[a]s with all products, to qualify as a medical device, an AVT product must have an intended purpose that meets the definition of a medical device.” The MHRA further provides that AVTs that are intended solely for transcription, summarizing of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices.
The guidance provides the following specific examples of non-medical device features:
- “Ambient scribe that is intended to provide a transcript of a clinical conversation between a clinician and a patient.”
- “Ambient scribe that is intended to provide a summary of a clinical conversation between a clinician and a patient.”
- “AVT product that formats information from transcripts/summaries of a given encounter into structured data for a clinician to review, edit and confirm for inclusion in problems lists, current medications lists, order sets or other similar forms of documentation.”
- “AVT product that suggests possible relevant clinical codes for review based upon a generated transcript or summary of a clinical conversation between a clinician and a patient.”
- “AVT product that drafts a discharge summary or letter for a clinician to review and edit, based on patient information from sources such as the electronic patient record or transcripts/summaries of conversations from a given encounter.”
The MHRA also provides the following examples of medical device functionality, consistent with the position that software intended to have a medical purpose is a medical device:
- “AVT product that provides a summary that includes an option for ‘generated insights’ based upon a clinical conversation between a clinician and a patient. These generated insights provide suggested diagnoses or relevant follow-up and treatment options.”
- “Ambient scribe that solely provides a summary of a conversation between a clinician and a patient, where the manufacturer claims that the product ‘guides diagnosis and treatment planning and improves patient outcomes.’”
- “AVT agent that operates as an ambient scribe and subsequently finalises and saves transcripts to the electronic patient record without requiring a clinician’s review. The product analyses the transcript to autonomously determine necessary follow-up tests and place the relevant orders without clinician input or confirmation.”
- “AVT product that can draft a report from a clinician’s dictation or a clinical conversation and a patient’s relevant test results from their electronic patient record. The product analyses these data and provides suggested diagnoses as diagnostic recommendations for a clinician’s review.”
Although NHS England’s prior guidance has been updated to refer to the MHRA’s new position and to remove prior statements suggesting AI scribes that summarize patient information are medical devices, it remains to be seen whether NHS England will change its internal policy or continue as part of its procurement strategy to request evidence of a CE/UKCA mark for AVTs intended for use within the NHS.
If you would like to discuss the latest medical device developments in the UK (or EU) and what they may mean for your company’s operations, please contact: Sarah Cowlishaw or Dan Spivey.