MHRA clarifies that AI scribes are not automatically medical devices

On 29 July 2026, the MHRA published new guidance on ambient voice technology (“AVT”) products, commonly known as AI scribes or ambient scribing tools. This is a significant development for anyone building or deploying AI-powered tools that document clinical consultations. In short, the guidance develops and clarifies the position taken by NHS England last year in respect of the classification status of AVTs as medical devices.

What are AVTs?

AVTs are AI-powered tools that can listen to consultations between patients and clinicians and produce useful outputs - typically a transcript, a summary, a referral letter, or a discharge note. As the AI has improved, these tools have moved well beyond simple transcription. Many now use large language models to process and restructure what was said in a consultation.

Clarifying earlier NHS guidance

In April 2025, NHS England issued guidance suggesting that AVTs using generative AI to summarise consultations should be treated as "high functionality" and would therefore likely qualify as a medical device.

NHS England's Chief Clinical Information Officer went further, issuing a "priority notification" stating that any ambient scribing software performing summarisation had to be regulated as at least a Class I medical device. This caused real problems.

Under the UK’s Medical Devices Regulations 2002, a product is only a medical device if its manufacturer intends it for a medical purpose, i.e. diagnosis, treatment, monitoring, and so on. NHS England’s position implied that summarisation alone could be enough, regardless of whether the product served any clinical purpose. A number of developers responded by seeking UKCA marking for products that arguably didn’t need it, just to stay on the safe side.

What the MHRA now says

The new guidance confirms the common-sense position: summarisation on its own does not make a product a medical device. The MHRA is clear that an AI scribe must have an intended purpose that meets the medical device definition before it falls within scope. Products that simply transcribe, summarise, structure data for a clinician to review, suggest clinical codes, or draft letters and discharge summaries are not medical devices, even where they use sophisticated AI to do so.

But a product crosses the line when it goes beyond administrative support. The MHRA gives clear examples: a tool that generates diagnostic suggestions, one marketed as “guiding diagnosis and treatment planning”, an AI agent that autonomously orders follow-up tests without clinician oversight, or a tool that produces suggested diagnoses alongside its draft report. In each case, the product is doing something clinical, not just clerical.

Two practical points worth flagging

• First, disclaimers don’t fix bad marketing. A generic statement like “this product is not for diagnosis” will not save you if medical claims appear elsewhere, e.g. in a sales deck, on a website, or in promotional material. Product and marketing teams need to be telling the same story.
• Second, the MHRA acknowledges that large language models can behave unpredictably, including hallucinating outputs. It confirms that unintended behaviour does not, by itself, create a new intended purpose. But manufacturers are still expected to design around known risks like hallucination - designing them out first, before relying on warnings - and to reassess a product’s regulatory status whenever new features change what it is intended to do.

NHS England’s position now

NHS England has updated its own guidance to reflect the MHRA's position and has withdrawn its earlier statements. It remains to be seen, however, whether NHS England's internal procurement practice will follow suit, or whether NHS bodies will continue to ask for evidence of a CE or UKCA mark for AVTs as a matter of course, even where none is legally required. The gap between the clarified regulatory position and day-to-day procurement practice may take time to close, so be ready to explain the non-device status of your product clearly.

A note on wider medical device reform

This guidance sits within a broader overhaul of the UK medical device framework. The MHRA published draft amending regulations in May 2026, marking the biggest overhaul of the UK’s medical device regulatory framework since Brexit.

Three points from the draft regulations are worth flagging in the context of AVT scribes:

• The introduction of a formal Predetermined Change Control Plan ("PCCP") pathway for software and AI medical devices. This would allow manufacturers to pre-specify the scope of future changes to an approved product, such as model updates or retraining, and have that scope reviewed and approved up front, so that changes falling within it can be made without a full re-certification each time. For AVT products that already sit within the medical device regime, for example because they generate diagnostic insights, this could materially reduce the regulatory friction of iterating a generative AI model over time.
• An International Reliance Pathway. A new standalone route to the GB market for devices already authorised by the US Food and Drug Administration, Health Canada, or Australia's Therapeutic Goods Administration. This would sit alongside, not replace, UKCA marking, and is expected to become operational in mid-2028. Notably, the EU is not currently included as a comparable regulator country under this pathway, so CE-marked devices continue to rely on the existing transitional recognition arrangements rather than this new route.
• Stricter classification rules that align more closely with the EU MDR, including the up-classification of certain software as a medical device. This means that AVT products which do fall within scope of the medical device definition may in time face a higher classification and correspondingly more onerous conformity assessment than they would under the current rules.

The key message, however, is that the underlying test for whether an AVT product is a medical device (intended purpose), is not changing. The MHRA’s guidance should therefore remain valid under the reformed framework.

The draft regulations are not yet law: adoption is anticipated towards the end of 2026, with core provisions expected to enter into force from around June 2027. Businesses should treat this as a live process to monitor rather than settled law, and factor the direction of travel into product roadmaps now.

What this means in practice

• For manufacturers - the intended purpose test should be reflected in your contracts, not just your marketing. If you want a product to sit outside the medical device regime, your product descriptions, warranties, and permitted use clauses all need to say so consistently. A warranty that a product is "fit for clinical decision support”, or a permitted use clause that allows diagnostic-style functionality, can pull an otherwise non-device product back into scope. Contracts should also include obligations to notify customers and reassess classification before deploying new features that go beyond summarisation or clinician-reviewed drafting.
• For NHS and other healthcare buyers - the risk runs the other way: assuming a product is a regulated medical device when it isn’t, and relying on the assurances that come with UKCA marking. Procurement teams should ask suppliers for a clear written statement of intended purpose and functionality, use that as the basis for risk allocation in the contract, and include rights to be notified if the product's functionality changes in a way that could affect its regulatory status.

The MHRA has drawn a clear line between administrative AI and medical devices. The job now is to make sure your contracts, your marketing, and your product roadmap all reflect where your product actually sits.

If you would like to discuss how this guidance affects your products or contracts, please get in touch.