AI Regulation Tracker / Medical devices
The MHRA drew the AI scribe device line at what the vendor claims, not at the technology
Two ambient scribes can do exactly the same thing and land on opposite sides of medical device regulation in Great Britain. The MHRA published the examples that show why, and the deciding factor is the manufacturer's stated purpose.
What did the MHRA actually publish?
A guidance note explaining how the existing medical device rules apply to ambient voice technology, the products most people call AI scribes. It sits under the UK Medical Devices Regulations 2002, using the classification rules in Annex IX of Directive 93/42/EEC. The document creates no new duty. Section 2 settles the bindingness question in its own words: MHRA guidance documents in general do not establish legally enforceable responsibilities, and describe the agency's current thinking, to be viewed as recommendations unless specific regulatory or statutory requirements are cited.
Treat that as a statement about the document, not about the consequences. If a product is a medical device, the device regulations bind it whether or not the guidance exists. This is the clearest published account of how the MHRA will read that question for this category, and it was written with NHS England, which is the buyer.
Where exactly does the line fall?
The guidance works through nine examples. Five are not medical devices. Four are. The guidance is explicit that the list is illustrative and not intended as an exhaustive list, so a product matching no row still has to be assessed on its own intended purpose. With that caveat, it is the most usable qualification test published for this category.
| Example | What the product does | Medical device? | Why |
|---|---|---|---|
| 1 | Produces a transcript of a clinical conversation | No | No medical purpose, so not a medical device |
| 2 | Produces a summary of a clinical conversation | No | Same conclusion. Summarising carries no medical purpose |
| 3 | Formats the transcript or summary into structured data for clinician review and confirmation | No | The clinician stays the decision point |
| 4 | Suggests possible relevant clinical codes for review, matching terms explicitly mentioned | No | Matching what was said is not interpretation |
| 5 | Drafts a discharge summary or letter for clinician review and edit | No | Drafting for review is not a medical purpose |
| 6 | Summary plus an optional generated insights feature offering suggested diagnoses or follow-up and treatment options | Yes | The insights feature carries a medical purpose. A disclaimer that insights do not replace traditional diagnosis or treatment did not change the outcome |
| 7 | Functionally identical to Example 2, but marketed as guiding diagnosis and treatment planning and improving patient outcomes | Yes | The claims alone establish the intended purpose. Same code, opposite classification |
| 8 | Agent that finalises and saves transcripts without clinician review and autonomously determines follow-up tests and places orders | Yes | Acting without clinician confirmation puts the product inside the clinical decision |
| 9 | Drafts a report and analyses data to provide suggested diagnoses as diagnostic recommendations | Yes | Diagnostic recommendation is a medical purpose |
Why do Examples 2 and 7 land on opposite sides?
Because qualification runs on intended purpose, and intended purpose is established by what the manufacturer says. Example 7 is the same product as Example 2. The difference is a marketing page claiming the product guides diagnosis and treatment planning and improves patient outcomes. That claim, on its own, makes it a medical device.
Vendors write that kind of copy because it sells. In Great Britain it now has a regulatory price, and the manufacturer pays it, not the marketing team that wrote the sentence.
The reverse move does not work either. The guidance states that general disclaimers, for example "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. It goes further on design: warnings are the lowest level of risk reduction, and manufacturers should mitigate risk by design first.
Use in a medical environment or context alone does not qualify a product as a medical device.MHRA, Ambient voice technology-enabled products
That cuts both ways, and it is worth holding onto. Selling into a hospital does not make a transcription tool a device. Claiming the tool guides diagnosis does.
What does Class IIa actually mean in practice?
Once a product is in scope, the classification rules decide how heavy the obligation is. Rule 12 is the default: all other active devices are class I. Rule 10 pulls active devices intended for diagnosis up to Class IIa where they allow direct diagnosis, which the guidance describes as providing the diagnosis by itself, providing decisive information for making a diagnosis, or where claims are made that the product can perform as, or support the function of, a clinician in performing diagnostic tasks.
Applied to this category, the guidance states that AVT devices intended to determine the probability of a patient having a disease or condition based on an analysis of a clinical interaction or other medical information, where such information is intended to be relied upon to determine treatment or clinical management options, may be considered as providing decisive information, and as such would be considered as providing a direct diagnosis under rule 10 and should be regulated as a class IIa medical device.
Class IIa is where the guidance stops being advisory in any practical sense. It states that certification by an approved body for UKCA, or a notified body for CE, is required. Approved body capacity is finite. A vendor that discovers on the eve of a trust rollout that its insights feature made the product Class IIa has a schedule problem measured in quarters.
Does this apply across the whole United Kingdom?
No, and this is the detail most summaries drop. The guidance addresses Great Britain: England, Wales and Scotland, under the UK Medical Devices Regulations 2002 with UKCA marking. Northern Ireland applies EU Regulation 2017/745 under the Windsor Framework. A vendor selling across the whole of the UK is operating under two device regimes at once, and this guidance speaks to only one of them.
There is a second scope boundary. Products that are not medical devices sit expressly outside this guidance. Their deployment in England is addressed by NHS England's separate guidance on AI-enabled ambient scribing products. A trust buying a transcription-only scribe does not escape governance, it answers to a different document.
What should a US health system or vendor do with this?
Two things, and neither of them is a UK compliance project.
First, use it as a diligence template. Pull the vendor's website, sales deck and product page, and read the claims as a regulator would. If the copy says the tool guides clinical decisions, the vendor has either accepted device status somewhere or has not thought about it. Both answers tell you something about the company you are about to embed in a clinical workflow.
Second, treat classification as a recurring question. The guidance flags feature creep directly: a product released initially without a medical purpose may be given features and new functions over time, those modifications may result in the product meeting the definition of a medical device, and manufacturers should assess the application of the device regulations with every change of their product. A scribe that was administrative tooling at signature can become a regulated device by silent update. Contract language requiring notice of any change to intended purpose or claims is cheap now and expensive to retrofit.
The guidance also names the failure mode underneath all of this. Hallucination is described as a well-known behaviour of generative AI with potentially broad impact in AVT products, and manufacturers are expected to design their products to behave consistently with their stated purpose. That expectation covers the non-device products too, where no approved body will ever look at it.
What the guidance does not do
It does not change the law. It does not create a registration or licensing regime for AI scribes. It does not cover Northern Ireland. It does not give a complete taxonomy, and it says so. And on the point the early coverage got wrong: it does not put summarising scribes into Class I. Some reporting on publication day stated that all AVT solutions generating summarisation need at least Class I device status. Example 2 says a product producing a summary of a clinical conversation does not have a medical purpose and is not a medical device. A team acting on that press summary would seek certification it does not need.
Frequently asked questions
Is an ambient scribe that summarises a consultation a medical device in Great Britain?
No, on the MHRA guidance as written. Example 2 is a product that produces a summary of a clinical conversation, and the guidance concludes that it does not have a medical purpose and is not a medical device. Some early coverage reported that summarisation requires Class I device status. The guidance says the opposite.
What tips an AI scribe into being a regulated medical device?
Four routes appear in the guidance examples: an insights feature offering suggested diagnoses or treatment options, marketing claims that the product guides diagnosis and treatment planning, autonomous action such as finalising records or ordering follow-up tests without clinician review, and analysis that produces diagnostic recommendations. Example 7 is functionally the same as the non-device Example 2 and qualifies only because of the manufacturer's claims.
When is an ambient voice technology product Class IIa rather than Class I?
Rule 12 of Annex IX makes all other active devices class I. Rule 10 puts active devices intended for diagnosis into Class IIa where they allow direct diagnosis. The guidance states that AVT devices intended to determine the probability of a patient having a disease or condition, where that information is relied upon to determine treatment or clinical management, may be considered as providing decisive information and should be regulated as a class IIa medical device. Class IIa requires certification by an approved body for UKCA or a notified body for CE.
Does this MHRA guidance apply in Northern Ireland?
No. It addresses Great Britain, meaning England, Wales and Scotland, under the UK Medical Devices Regulations 2002. Northern Ireland applies EU Regulation 2017/745 under the Windsor Framework, so a product sold there is assessed under the EU rules instead.
Last verified: July 29, 2026