Your AI scribe's status is set by marketing

Read MHRA's ambient voice technology guidance to the end and you reach Example 7, which is where the practical problem lives. It describes an ambient scribe that, in MHRA's own words, is "identical in function to the ambient scribe described in Example 2". Example 2 is not a medical device. Example 7 is. The only thing that changed between them is that the manufacturer of the second one claims the product "guides diagnosis and treatment planning and improves patient outcomes".

Same software. Same outputs. Same clinician reviewing them. One sits outside the UK Medical Devices Regulations 2002 entirely, and one requires UKCA certification before it can lawfully be placed on the Great Britain market. The line is drawn by the vendor's website, not by the code.

That is the sentence in the guidance published by the Medicines and Healthcare products Regulatory Agency on 29 July 2026 that nobody reported, and it is the one that matters most to a private psychology group choosing a scribe this month. It means your due diligence question has to change from "what does this tool do" to "what does this company say it does, everywhere it says anything".

Five functions, not four

The MHRA press release of 29 July 2026 lists four exempt activities: transcription, summarising clinical conversations, drafting letters, and suggesting clinical codes for a clinician to review. Almost all the trade coverage since has repeated that four.

The guidance document itself sets out five worked examples of AVT products that do not qualify as medical devices. The one the press release compresses away is Example 3: a product that formats information from a transcript into structured data for a clinician to review, edit and confirm into problem lists, current medication lists or order sets, including presenting reminders or checks for potentially missing data. MHRA's reasoning is that the product creates structure from information already present and "is not intended to derive or recommend any new information to impact the clinician's clinical decision making".

That fifth example sits closest to the line, because a prompt about missing data starts to look like a clinical prompt if the vendor describes it in the wrong register.

So what for you: if a supplier tells you their product is covered by "the four functions MHRA exempted", they are quoting a press release rather than the guidance, and that is a reasonable early signal about how carefully they have read the rest of it.

The test is intended purpose, and intended purpose is a marketing artefact

Under the UK MDR, a medical device is anything intended for diagnosis, prevention, monitoring, treatment or alleviation of disease, among other purposes. MHRA is explicit that a product's intended purpose "is defined by the claims in its instructions for use, labelling, and the manufacturer's promotional materials (e.g. websites and adverts)".

Two consequences follow, and both are the practice's problem rather than the vendor's.

First, a disclaimer does not save a product. MHRA states that general disclaimers such as "this product is not for diagnosis" are "not acceptable to demonstrate a product is not a medical device if medical claims are made or implied elsewhere in the product labelling or associated promotional material, including those made on websites, sales presentations, or online advertisements". Example 6 is exactly this case: a scribe with an optional "generated insights" feature surfacing suggested diagnoses or treatment options, carrying an in-product warning that it does not replace traditional diagnosis. MHRA's finding is that the warning does not matter, because the feature is highlighted in the interface and discussed in sales material.

Second, a sales presentation is promotional material. The claim that changes a product's regulatory status can be made in a demo deck you were shown once and never received a copy of.

So what for you: before you sign, capture the vendor's claims in writing. Ask for the intended purpose statement, ask whether the product holds a UKCA mark, and if the answer is that no mark is needed because the product is not a device, ask them to confirm in the contract that no diagnostic or treatment claim appears in any of their promotional material. That is a fair question, and a supplier who has done this properly will answer it in a sentence.

The exemption is a snapshot, not a certificate

The guidance is unusually direct about products changing underneath their own classification. MHRA notes that AVT products "are increasingly being designed with flexible underlying technology that can enable manufacturers to rapidly deploy more complex uses beyond the scope of such initial intended purposes", and that "manufacturers should assess the application of the device regulations with every change of their product".

A generative AI scribe is shipped as software. Software updates arrive silently. A tool that was correctly outside the regulations when you procured it in March can acquire an insights panel in October and become a device that has never been through an approved body. The manufacturer carries the legal duty to reassess. You carry the clinical governance consequence of running it.

MHRA also flags hallucination directly, describing it as "a well-known behaviour of GenAI with potentially broad impact in AVT products", and states that manufacturers should mitigate risk by design first and treat warnings as the lowest level of risk reduction. That is a useful line to have in writing, because it is the opposite of how most vendor onboarding handles the issue. We have covered how far apart published hallucination rates for clinical scribes actually sit, and the answer is far enough that "the clinician reviews it" is doing a lot of unexamined work.

So what for you: put a release-notes review into your governance cycle. Once a quarter, someone in your practice should read what changed in the product and ask whether any new feature generates information that was not said in the room. That is a fifteen-minute job if it is scheduled and an emergency if it is not.

Why psychology sits closest to the line

Every one of MHRA's five exempt examples turns on the same condition: the product presents information that was already in the encounter, and adds nothing new for the clinician to rely on. Transcribing meets that easily. Coding meets it because MHRA restricts the exempt case to codes matched to terms "explicitly mentioned" in the discussion, not deduced from implicit information.

Summarising a therapy session is where the condition gets uncomfortable. A useful psychological summary is not a compression of what was said. It selects, weighs and frames: which theme recurred, what the client avoided, how presentation shifted between sessions, whether risk moved. The moment a product is designed or described as producing formulation content, risk flags or suggested treatment direction, it is deriving new information rather than reorganising existing information, and it has moved into MHRA's Example 6 territory.

None of that argues against using AVT in psychology. It argues for being precise about which features you switch on and how the supplier describes them. Note also that MHRA's guidance addresses device qualification only. It does not touch your consent position, which is governed separately, and where the binding standard comes from HCPC rather than from professional body guidance. A product being outside the medical device regulations tells you nothing about whether you may lawfully record a client.

So what for you: treat the phrases "insights", "clinical suggestions", "risk detection" and "outcome prediction" as procurement stop signs in a therapy context. Any of them turns a purchase into a regulated device purchase, at which point you need to see the certification, not the brochure.

What MHRA deliberately did not cover

The guidance contains one sentence that independent practice owners should read twice: "the approach to non-device products is outside the scope of this guidance". MHRA then points readers to NHS England's guidance on AI-enabled ambient scribing products, which is written for health and care settings in England and was updated in July 2026 to align with the MHRA position.

Follow that chain and the gap becomes obvious. If your scribe is exempt, MHRA is not telling you how to deploy it safely, and the document that does is aimed at NHS organisations. A private psychology group in Bristol or an independent physiotherapy practice in Glasgow is the intended reader of neither, while buying the same products.

The scope is also narrower than the coverage implies geographically. The guidance applies to Great Britain, meaning England, Wales and Scotland. Under the Windsor Framework, EU Regulation 2017/745 applies in Northern Ireland, so a Belfast practice is assessing the same tool against a different regulation.

Against that, note what happened a week later. On 6 August 2026, the Health Services Safety Investigations Body opened a patient safety investigation into the use of ambient voice technology in hospitals, having found that adoption is accelerating while the safety implications are not fully understood. Its report is expected in summer 2027. Two national bodies looked at the same technology in the same fortnight: one confirmed most of it falls outside device regulation, the other opened a harm investigation into it. Both positions are coherent. Not being a medical device has never meant not being a safety risk.

So what for you: the exemption removes a regulatory hurdle from your supplier. It does not remove a governance duty from you, and there is currently no regulator writing that duty down for independent practice. You have to write it yourself, which is what our practice-level AI governance checklist was built for.

If it is a device, the class matters

Practices tend to hear "medical device" and assume a single tier of approval. There are two here, and the gap between them is money and lead time.

MHRA applies the classification criteria in Annex IX of Directive 93/42/EEC under the UK MDR 2002. Rule 12 puts all other active devices in class I, which a manufacturer can self-declare. Rule 10 puts active devices intended for diagnosis in class IIa, which requires certification by an approved body. MHRA's guidance states that AVT devices intended to determine the probability of a patient having a condition based on analysis of a clinical interaction, where that information is relied on to determine treatment or management options, may be providing "decisive information for making a diagnosis" and should be regulated as class IIa.

Class IIa certification takes months and costs real money, which is why some suppliers would much rather their product were not one. That commercial pressure is the thing to keep in mind when a salesperson is confident that their insights feature is administrative.

So what for you: if a product makes any probabilistic clinical claim, ask for the UKCA certificate and the approved body number. An answer that is not a certificate number is a no.

The recommendation

Do this before your next AVT renewal or purchase, and it should take an afternoon.

Ask the supplier for their written intended purpose statement and their device qualification position, in that order. Screenshot every claim on their website, in their sales deck and in any advert you have seen, and keep the file. Read the feature list for anything that generates content not said in the session, and get written confirmation of whether it can be disabled at tenant level rather than per user. Schedule a quarterly release-notes review with a named owner. Record, in one paragraph, why you concluded the product is or is not a medical device, and date it. If MHRA or the supplier's position changes later, that paragraph is the evidence that you assessed it properly at the time, which is the whole substance of a well-led governance case.

Frankly, most independent practices will find the first step is the hard one, because it surfaces how little of the vendor's claim set was ever captured in writing during procurement. That is the same gap we keep finding when accuracy carries almost no weight in how these tools are actually selected.

If you want that assessment done properly across every AI tool in the practice rather than one at a time, our AI Opportunity and Growth Assessment covers exactly this: what is running, what it claims, what it does with clinical data, and who is accountable for each output. Or book a 20-minute call and we will tell you whether it is worth doing at all.

Related: HCPC's consent standard is binding. BPS's AI guidance isn't.  ·  Dental AI scribes: the hallucination rate no vendor agrees on  ·  The CQC AI governance checklist for independent practices

This article is for informational purposes only and does not constitute legal or clinical advice. It summarises the text of "Ambient voice technology-enabled products", MHRA guidance published 29 July 2026 on GOV.UK, together with the accompanying MHRA press release of the same date and the HSSIB investigation notice of 6 August 2026. MHRA states that its guidance documents describe current thinking and should be viewed as recommendations rather than legally enforceable responsibilities unless specific regulatory or statutory requirements are cited. Device qualification for any specific product is a matter for its manufacturer and, where relevant, the MHRA. Confirm your own position with the MHRA customer service centre and your professional indemnity provider before acting on anything above.