Is an AI scribe a medical device? What the MHRA's July 2026 guidance means for therapists

An AI scribe, which the MHRA calls ambient voice technology, is a tool that captures what is said in a consultation and turns it into text or other outputs, such as a summary or a letter. The question of whether it is a medical device matters because medical devices must meet legal requirements before they can be placed on the market in Great Britain.

On 29 July 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) published guidance called Ambient voice technology-enabled products. NHS England and the MHRA sent a joint letter to NHS leaders the same day. This article explains what the guidance says, where the line sits, and what it changes for a counsellor, psychologist or allied health practitioner in private practice.

What the MHRA published on 29 July 2026

The guidance was published on 29 July 2026 and updated on 31 July 2026. It explains how the existing UK Medical Devices Regulations 2002 apply to AI scribes. The MHRA press release is clear on this point. The guidance does not change the law. It sets out how the current rules apply.

A few points frame everything else.

• It is guidance, not law. It gives the MHRA's current thinking and should be read as recommendations, except where it cites a legal requirement.
• It covers Great Britain, so England, Wales and Scotland. Northern Ireland follows the EU Medical Device Regulation under the Windsor Framework.
• The press release title mentions the NHS, but its text refers to products "used in health and care settings in Great Britain".
• It does not mention mental health, psychology or therapy. Its examples come from general clinical settings.

The guidance also says that use in a medical setting is not enough on its own. In its words, "Use in a medical environment or context alone does not qualify a product as a medical device." What counts is the product's intended purpose.

When an AI scribe is not a medical device

The guidance gives five worked examples of AI scribes that are not medical devices. Each one supports an administrative task, and in each one a clinician checks the output.

• Transcription. A transcript of the conversation that the clinician reviews and corrects.
• Summary. A summary of the encounter for the clinician's review, with no clinical suggestions beyond what was discussed. The guidance says this product "does NOT have a medical purpose and is NOT a medical device."
• Structuring. Turning what was said into structured data, such as a problem list or a medication list, for the clinician to confirm. The tool is not intended to derive or recommend new information.
• Clinical coding. Suggesting codes that match clinical terms said explicitly in the conversation. The tool does not infer diagnoses or codes from things that were only implied.
• Letters and discharge summaries. Drafting them from the conversation and existing data, with no new clinical recommendations.

The common thread is simple. The tool writes down and organises what was said. It adds nothing clinical of its own. A person reviews the result.

When an AI scribe becomes a medical device

The guidance then gives four examples of AI scribes that are medical devices.

• Generated insights. A product that offers insights suggesting diagnoses, follow-up or treatment options is a medical device. This holds even if it shows a warning that the feature is not intended to replace traditional methods of diagnosis or treatment.
• Marketing claims. A scribe with exactly the same functions as the summary example becomes a medical device if it is marketed as one that "guides diagnosis and treatment planning and improves patient outcomes."
• Autonomous action. An agent that saves transcripts without clinician review and places orders for follow-up tests without clinician input is a medical device.
• Suggested diagnoses. A report drafting tool that also suggests diagnoses, where the reasoning may be shown only in a limited way or not at all, is a medical device.

The press release puts it in one line. Products intended to support diagnosis, treatment or prevention, or that take automated action such as placing orders without clinician review, are regulated as medical devices. Lawrence Tallon, Chief Executive Officer of the MHRA, said that "where a product supports diagnosis or treatment, regulatory protections will still apply."

Marketing counts as much as features

This part is easy to miss. Under the guidance, a product's intended purpose comes from its labelling, its instructions for use and its promotional material. The guidance names claims made "on websites, sales presentations, or online advertisements."

So two tools with the same code can sit on different sides of the line. One is sold as a note-taking aid. The other is sold as something that guides treatment planning. The second one is a medical device because of what its maker says about it.

Disclaimers do not fix this. The guidance says that general disclaimers, for example "this product is not for diagnosis", are not acceptable as proof that a product is not a device when medical claims are made or implied elsewhere. It also says that "Warnings are the lowest level of risk reduction." Makers are expected to reduce risk through design first.

Two more points matter for buyers. Using a particular technology does not by itself decide a product's intended purpose. And new features can change the intended purpose. The guidance says manufacturers should check how the device rules apply each time they change their product.

Class I or Class IIa

When an AI scribe is a medical device, it still has to be classified. The guidance uses the classification rules the UK Medical Devices Regulations apply.

• Active devices intended for diagnosis fall under Rule 10 and are Class IIa. Some are Class IIb, for example devices specifically intended to monitor vital physiological parameters where changes could result in immediate danger to the patient.
• A device "allows direct diagnosis" if it gives the diagnosis itself, provides "decisive information for making a diagnosis", or claims to perform or support a clinician's diagnostic function.
• A product that estimates the probability of a patient having a disease, where clinicians are meant to rely on that estimate for treatment or clinical management, may be considered as providing decisive information. The guidance says it should be regulated as Class IIa.
• Other active devices fall under Rule 12 and are Class I.

Class IIa and above need certification by an approved body (for UKCA marking) and/or a notified body (for CE marking). The guidance itself does not cover registration steps.

One gap is worth naming for mental health. The guidance does not mention features that score or flag clinical risk, such as risk of self-harm. None of its worked examples covers them. If a tool you are considering offers such a feature, ask the vendor in writing how it has classified it and why.

What the NHS asks for, as context

Most private practitioners will never buy through the NHS. The NHS rules are still useful as a benchmark.

The joint NHS England and MHRA letter of 29 July 2026 asks NHS organisations to check what a product can do and to ensure it has "the appropriate medical device certification, where applicable." It says users remain responsible for reviewing, validating and approving AI generated information before it is relied on for care. It also notes that outputs "may contain inaccuracies and require review."

NHS England also has separate guidance on the use of AI-enabled ambient scribing products, version 2, for England. No publication date appears on the page. Among other things, it says:

• Suppliers on the national AVT Supplier Registry must hold "at least MHRA Class 1 Registration". NHS England says it does not endorse any supplier on the registry.
• Suppliers are expected to complete the Digital Technology Assessment Criteria (DTAC) and the DCB0129 clinical safety standard. Deploying organisations complete DCB0160 and a Data Protection Impact Assessment (DPIA).
• Users should "review and approve any product outputs prior to further actions."
• Organisations should be transparent about how information is used and shared. One way the guidance gives is to explain this to patients before the processing takes place, giving them the chance to object.

Note that this NHS page uses different wording from the MHRA. It says that adding generative AI summarisation is likely to make a product a medical device. The MHRA guidance of 29 July 2026 says a summary for clinician review, with no clinical suggestions, is not a device. On the legal question of device status, the MHRA is the regulator. The NHS registry requirement is a procurement rule for NHS use.

What it means for a private therapist

The MHRA guidance is mostly aimed at manufacturers, who set a product's intended purpose. As a practitioner, you do not classify the product. But you choose it, and you stay responsible for the notes you sign. The press release says clinicians remain responsible for reviewing and verifying AI outputs before using them in care.

In practice, this gives you a short checklist you can apply to any AI scribe, Delta included.

1. What exactly does the tool output?

Look at a real example. Is it a transcript, a summary, a structured note or a draft letter? Or does it add things nobody said in the session?

2. Does it suggest a diagnosis, a risk level or a treatment?

Look for sections such as "possible diagnosis", "suggested interventions", "risk score" or "recommended next steps" that go beyond what was discussed. Under the guidance, these are the features that can turn a scribe into a device.

3. Read the marketing, not only the product

Open the vendor's website, adverts and sales slides. Look for claims such as "supports diagnosis", "guides treatment planning" or "improves outcomes". If you find them, the product may be a medical device whatever its small print says.

4. If it claims device functions, is it registered and classified?

Ask the vendor which class it has chosen and for evidence. A tool that offers diagnostic support without a device classification is a warning sign.

5. Who reviews the output before it is final?

Check that nothing is saved, sent or acted on without your approval. The guidance treats autonomous action as a device feature.

6. What happens when features change?

Ask how the vendor will tell you if a new feature changes the product's status. The guidance says new features can change intended purpose.

Device status is only one question. Data protection, consent and confidentiality are separate. We cover those in our guides to AI notes for therapists in the UK and the risks of AI in clinical psychology. For a comparison of tools, see the best AI scribes for therapists in the UK. If you use a general chatbot for notes, our comparison of Delta and ChatGPT explains the differences.

How Delta works

Delta is an AI assistant for mental health and allied health practitioners. During the session, Delta transcribes what is said, then prepares a session report that you review. You can also dictate observations right after the session or add written notes. The report is added to the client's file, so the whole follow-up is in one place. Delta also drafts assessment reports, letters and certificates, which you review and validate before use. You can read more about automatic session transcription.

Data is hosted in France with a host certified for health data (HDS, the French health data hosting certification), and AI processing, transcription included, runs on servers in France. The client's name and identifying details are pseudonymised before AI processing, no audio file is kept, data is never used to train models, and data is encrypted in transit and at rest. Details are on our security page.

You can apply the six questions above to Delta as to any other tool.

Sources

All pages opened on 9 October 2026.

• MHRA, Ambient voice technology-enabled products (guidance, 29 July 2026)
• MHRA, press release: MHRA clarifies regulatory status of ambient voice technologies used in the NHS
• NHS England and MHRA, Medical device regulation for ambient voice technology products (letter, 29 July 2026)
• NHS England, Guidance on the use of AI-enabled ambient scribing products in health and care settings (version 2)