MHRA rules AI scribes that only transcribe or summarise are not medical devices

The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on 29 July 2026 setting out how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain. The agency said the guidance was developed "in close partnership with NHS England" ¹.

What the guidance says

AVT products that are intended solely for transcription, summarising clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices under the current framework. Products intended to support diagnosis, treatment or prevention, or that take automated action such as placing orders without clinician review, are medical devices and must meet the relevant safety and performance requirements. The MHRA said the guidance "does not change the law" ¹.

The guidance document gives 9 illustrative examples. Five describe products that are not devices: a scribe that produces a transcript, a scribe that produces a summary, a tool that formats encounter information into structured data for the clinician to confirm, a tool that suggests clinical codes by matching terms explicitly said in the conversation, and a tool that drafts a discharge summary or letter from the encounter and the patient record ².

Four describe products that are devices: a summary tool with a "generated insights" option that suggests diagnoses or treatment options, a summary-only scribe whose manufacturer claims it "guides diagnosis and treatment planning and improves patient outcomes", an agent that saves transcripts to the record and places follow-up orders without clinician review, and a report tool that recommends diagnoses ².

The document states that general disclaimers such as "this product is not for diagnosis" are not acceptable if medical claims are made elsewhere in labelling or promotional material, and that manufacturers "should assess the application of the device regulations with every change of their product". An AVT device that provides decisive information for making a diagnosis falls under rule 10 and should be regulated as a class IIa device, which requires certification by an approved body ².

Lawrence Tallon, Chief Executive Officer of the MHRA, said: "We are setting out which functions of ambient voice technologies are deemed medical devices and which are not in order to remove ambiguity." Rob Thompson, Chief Digital, Data and Technology Officer at NHS England, said: "We'll now begin rolling out the technology across the NHS safely, consistently and at scale" ¹.

What it means for the market

For NHS buyers, the guidance adds board-level duties. NHS boards and executive teams are asked to assure themselves that AVT deployment is supported by appropriate clinical oversight, local governance, staff training and procurement processes, and that any change in a product's functionality that may alter its regulatory status is identified and reviewed. Clinicians remain responsible for reviewing and verifying AI-generated transcripts, summaries and other outputs before they are used in patient care ¹.

For suppliers, the line is drawn by intended purpose and marketing claims rather than by the underlying technology. A scribe with purely administrative functions becomes a device if it is marketed as improving patient outcomes, and a new feature can move a product across the line ². techUK, in a position statement dated 14 August 2026, welcomed the guidance and noted that NHS trusts and integrated care boards "retain the ability to set their own procurement requirements", including specifying medical device classification as a condition of purchase ³.

The sources give no figures for how many products or NHS organisations are affected, and NHS England's rollout statement carries no timetable or funding detail ¹.

The MHRA says its guidance documents "do not establish legally enforceable responsibilities" and describe its current thinking, and that the examples are not an exhaustive list. Non-device products are outside the guidance's scope; NHS England has issued separate guidance for those adopting ambient scribing products in England. The document also names hallucination as "a well-known behaviour of GenAI" that manufacturers should mitigate by design before relying on warnings ².

Two further pieces of work are due. NHS England and the Royal College of Psychiatrists said on 6 May 2026 that they will publish guidance on AVT use with patients with mental health needs, learning disabilities or neurodivergent people by September 2026 ⁴. The Health Services Safety Investigations Body notified an investigation on 6 August 2026 into the use of AVT in acute adult secondary care and expects to publish its report in summer 2027 ⁵.