The short answer
A scribe that only transcribes or summarises the appointment for you to check is not a medical device. One that suggests diagnoses or treatment, acts without a clinician confirming, or is marketed as guiding diagnosis or improving outcomes is a medical device.
A tool that gives decisive information for a diagnosis falls in Class IIa, which needs independent certification. A disclaimer in the small print does not change any of this.
What the MHRA published
The MHRA’s guidance on ambient voice technology was published on 29 July 2026 (MHRA). It applies to medical devices on the Great Britain market: England, Scotland and Wales. Northern Ireland follows the EU medical device rules instead. The guidance is advice, not law in itself, except where it points to a legal requirement.
The key idea is intended purpose. Whether a product is a device depends on what it does and on what the maker says it is for, in “its instructions for use, labelling” and promotional material. Using AI does not, on its own, make something a device.
NHS England updated its own ambient scribing guidance the same day to match (NHS England AVT guidance). Neither document mentions dentistry, but both apply to dental practices as they do to any other care setting.
The nine examples, in dental terms
The guidance works through nine products. The first five are not medical devices; the last four are. The dental versions are ours, to show how each applies in a surgery.
| Example | What the product does | In a dental surgery | Medical device? |
|---|---|---|---|
| 1 | Writes a transcript of the conversation. | A word-for-word transcript of a recall exam. | No |
| 2 | Summarises the conversation, with no clinical suggestions. | A draft note of the exam for the dentist to check. | No |
| 3 | Turns the transcript or summary into structured data. | The medicines a patient lists go into the medical history fields. | No |
| 4 | Suggests codes for clinical terms that were said out loud. | The dentist says a treatment; the tool offers its code for review. | No |
| 5 | Drafts a letter or summary for the clinician to edit. | A referral letter to an endodontist, edited before sending. | No |
| 6 | Adds “generated insights”: suggested diagnoses or treatment options. | From the symptoms, it proposes irreversible pulpitis and root canal treatment. | Yes |
| 7 | Works like example 2, but is marketed as guiding diagnosis and improving outcomes. | The same draft note, sold as helping you diagnose. | Yes |
| 8 | Finalises and acts on its output without a clinician confirming. | Files the note in the record, or books treatment, with no dentist sign-off. | Yes |
| 9 | Drafts a report from dictation and test results, and suggests diagnoses. | Reads a radiograph report with the dictation and proposes a diagnosis. | Yes |
Example 6 is a device even though its screen warns that the insights are not meant to replace usual diagnosis. Example 4 stays outside the rules because it only matches terms that were said out loud; it doesn’t work out a diagnosis or code from what was implied.
Why the marketing matters as much as the software
Example 7 does exactly what example 2 does. It becomes a medical device because its maker claims it “guides diagnosis and treatment planning” and improves patient outcomes. The MHRA adds that general disclaimers “are not acceptable” to show a product isn’t a device when medical claims are made or implied elsewhere (MHRA).
So read a scribe’s website and brochures, not just its settings screen. On our reading, phrases like “safer care”, “better clinical decisions” or “never miss a finding” point the same way as example 7. The MHRA also says makers should reassess “with every change” to the product, so a tool that adds a suggestions feature can change category.
What a “Class I” or “MHRA registered” badge means
Under the UK rules the guidance quotes, active devices intended for diagnosis are Class IIa, and other active devices are Class I. Class IIa and above need certification by an approved body (UKCA) or a notified body (CE) (MHRA). Class I devices generally don’t: the maker registers the product and declares that it conforms.
Registration is not approval. The MHRA says registering a device “does not represent any form of accreditation, certification, approval or endorsement” (MHRA). Registered devices are listed on the MHRA’s public database, PARD.
None of this says a Class I scribe is doing anything wrong. But if a scribe suggests diagnoses, the MHRA’s guidance points to Class IIa, so it is fair to ask which features a Class I registration covers.
Questions to ask a vendor
- Does it ever suggest a diagnosis, a treatment or a code for something nobody said?
- Can anything reach the patient record without a clinician confirming it?
- What do your website and brochures claim it does for patient care?
- Is it a medical device? If so, which class, which features does that cover, and where is it on PARD?
- Who reassesses its status when you add features, and how will you tell us?
- Can we see your DCB0129 clinical safety case report?
NHS England’s guidance also asks practices to check a product’s device status before using it (NHS England). If you’re unsure about a product, the MHRA takes questions at info@mhra.gov.uk.
Where Squte stands
Squte drafts a transcript and a note for the dentist to check, change and sign, as in examples 1 and 2. It records a diagnosis only when the dentist states one, in their words, and never suggests a diagnosis or treatment. In October 2026 we removed a feature that pre-filled the diagnosis line from charting findings, because under this guidance that counts as a suggestion.
Nothing reaches the record until the dentist signs, and Squte never writes into the practice system itself. We make no claims about clinical outcomes. On our reading of the guidance, Squte stays outside medical-device rules; we are asking a regulatory adviser to confirm it, and we will review that each time we change what it does.
For the rest of what a practice needs before using a scribe, see the governance pack.
Read next
- Is an AI-written dental note defensible? →Who is responsible for an AI-drafted note, what the defence bodies say, and how to review one.
- Patient consent for AI scribes →A consent kit for UK dental practices: what to say, when to tell patients, recording a refusal, poster and privacy-notice wording.
- Governance pack →What a practice needs before using an AI scribe: Squte’s data flows for your DPIA, a DCB0160 hazard-log starter, and where to find the patient poster and privacy-notice wording.
Try it on your own appointments.
Squte is an AI dental scribe for UK dentists. It asks the patient’s consent, records the appointment and drafts a UK 17-section clinical note for the dentist to check, change by voice and sign.
14 days or 100 visits, whichever comes first. Card required, and nothing is charged during the trial. Then from £25 a month, no VAT to add. Cancel before the trial ends and you pay nothing.
General information, not legal, clinical or tax advice. Squte makes AI dental scribe software, so we have an interest in this subject; every fact above links to its source. How we write. Found an error? Email hello@squte.co.uk and we correct verified errors within five working days.