Ambient voice technology and AI scribes in the NHS: the rules for suppliers and buyers (2026)

AI scribes in the NHS: NHS England guidance, the July 2026 MHRA medical device position, the AVT supplier registry and what buyers and suppliers must do.

Short answer. AI scribes (ambient voice technology, AVT) listen to a consultation and draft the note, letters or codes for the clinician to review. NHS England wants them deployed at pace, publishes guidance on safe use and runs a self-certified supplier registry (30 suppliers as of October 2026; not a procurement framework). Since 29 July 2026 the MHRA's position is that AVT that only transcribes, summarises, drafts or suggests codes for review is not a medical device; AVT that supports diagnosis or treatment, or acts without clinician review, is. Suppliers still need DTAC, DCB0129 and DSPT evidence; NHS buyers need a CSO, DCB0160, a DPIA and independent monitoring.

This guide is for healthtech founders building AI scribe or voice products and for NHS and private providers buying them. It summarises the national guidance, the MHRA position, the registry, the evidence on benefits and the practical steps on each side.

Last checked: 2 November 2026.

This is a general guide for suppliers, not legal or regulatory advice. Magora is a software developer, not your regulatory advisor. NHS integration and assurance rules change often, so check the current NHS England pages linked below before you plan or submit anything.

What ambient voice technology does

An AI scribe records the conversation between clinician and patient, transcribes it and uses a language model to produce outputs such as a structured clinical note, a referral or discharge letter, or suggested clinical codes. The clinician reviews and approves the output before it goes into the record. NHS England's scaling programme starts in outpatients and names clinical coding and discharge summaries as future uses.

Is an AI scribe a medical device? The 2026 MHRA position

On 29 July 2026 the MHRA published guidance on ambient voice technology-enabled products, developed with NHS England. It says the guidance does not change the law but clarifies how it applies:

Source: MHRA, Ambient voice technology-enabled products, version 1.0, 29 July 2026.

Three points from the guidance matter for suppliers. The intended purpose is judged from your labelling, instructions and promotional material, including your website and sales material, so a "not for diagnosis" disclaimer does not help if medical claims appear elsewhere. Hallucination on its own does not create a new intended purpose, but you must design out known risks and reassess at every feature change. And if your product is a device, it is usually Class I, or Class IIa if it provides information used directly for diagnosis, which needs an approved body.

Earlier NHS England guidance had treated summarising scribes as Class I devices at minimum. Some NHS buyers and procurement documents may still ask for Class I registration, so be ready to explain your intended purpose against the MHRA guidance.

What NHS England expects from deploying organisations

NHS England's guidance on AI-enabled ambient scribing products, first published in April 2025 and updated on 29 July 2026, sets out what an NHS organisation must do:

• assign a Clinical Safety Officer and complete DCB0160 documents: safety case, hazard log and monitoring framework;
• complete a DPIA; patients should be told at the start of the consultation and may object;
• check the supplier's DCB0129 work, DSPT and Cyber Essentials, and the product's medical device status;
• make sure clinicians review and approve every output before it is used;
• train staff, monitor accuracy independently of the manufacturer, and test with different accents and dialects;
• integrate with the electronic patient record, in most GP settings through IM1;
• treat pilots, of up to four months, as subject to the same compliance, and contract clearly on liability.

The guidance also flags the risks that matter most for language models: omissions, misreading context, prompt injection, unintended functions triggered by user prompts and automation bias.

The AVT self-certified supplier registry

NHS England runs an Ambient Voice Technology Self-Certified Supplier Registry, which listed 30 suppliers in October 2026, including Accurx, Tortus, Heidi Health, Microsoft Dragon, Corti and others. Suppliers self-certify against criteria including DTAC compliance, evidence of real-world NHS benefit, a performance monitoring approach, safeguards against misuse and integration capability. NHS buyers see the evidence through the national commercial and procurement hub.

It is important to read it correctly: the registry is not a commercial framework, NHS England does not endorse the suppliers, and each NHS organisation still procures under its own governance. Applications reopened on 3 February 2026 and remain open.

What the evidence says

The most cited evaluation was sponsored by NHS England and led by Great Ormond Street Hospital's DRIVE unit, using one product across nine London NHS sites and more than 17,000 patient encounters. It reported:

Source: GOSH news release, 4 September 2025, repeated by NHS England. No full paper was published on that page, the economic figures were modelled, and one vendor was evaluated.

What suppliers should prepare

1. Write the intended purpose carefully and keep every web page, deck and sales email consistent with it.
2. DTAC v2.0 evidence, including DCB0129 clinical safety documents with a CSO. See our DTAC guide and DCB0129 guide.
3. Data protection: a DSPT, UK or EEA hosting, clear processor terms, and controls on what audio and text the model provider may keep.
4. Accuracy and monitoring: an evaluation set covering specialties, accents and noisy rooms; monitoring in live use; a process for reporting errors.
5. Integration with clinical systems, for example IM1 in GP settings. See our guide to GP Connect and NHS APIs.
6. Evidence of benefit in NHS settings, collected from the first pilot.

Building an AVT product, or adding AI scribing to yours

Many health products do not need to become a scribe vendor; they need AI drafting inside their own workflow, for example a clinic system that drafts the follow-up letter. The same rules apply: clinician review, clear intended purpose, clinical safety and data protection. At Magora an AI proof of concept costs from £10,000 in 4–6 weeks, and our health AI work includes BodySync, which drafts physiotherapy treatment plans for clinicians from structured assessment data and peer-reviewed sources. See AI development cost in the UK.

Building AI into a clinical product? Send us a brief: we will build a free working prototype on sample data in 5–10 working days and plan the clinical safety and data protection work with your CSO in Discovery. More about our healthcare software development.

Frequently asked questions

What is ambient voice technology in the NHS?

Ambient voice technology (AVT), or AI scribing, listens to a consultation and produces a transcript, a structured clinical note, letters or suggested codes for the clinician to review. NHS England's planning guidance directs NHS organisations to deploy AVT at pace, and it publishes guidance and a self-certified supplier registry.

Is an AI scribe a medical device?

According to MHRA guidance published on 29 July 2026, AVT used only to transcribe, summarise, draft letters or discharge summaries, structure data or suggest codes for clinician review is not a medical device. AVT intended to support diagnosis, treatment or prevention, or to take automated actions such as placing orders without clinician review, is a medical device.

What is the NHS AVT supplier registry?

NHS England's Ambient Voice Technology Self-Certified Supplier Registry lists suppliers that have self-certified against its criteria, including DTAC compliance and evidence of NHS benefit. It is not a commercial framework, NHS England does not endorse the suppliers, and each NHS organisation procures under its own governance.

What must an NHS organisation do before deploying an AI scribe?

Assign a Clinical Safety Officer, complete DCB0160 documents and a DPIA, check the supplier's DCB0129 work, make sure clinicians review and approve outputs, train staff, monitor accuracy independently, test accents and dialects, integrate with the electronic record, check DSPT and Cyber Essentials, and check medical device status.

How much time do AI scribes save?

An NHS England-sponsored evaluation led by Great Ormond Street across nine London sites and more than 17,000 encounters reported direct patient interaction time up 23.5% and appointment length down 8.2%. Results depend on setting and product.

What should suppliers of AI scribes prepare?

DTAC v2.0 evidence, DCB0129 clinical safety documents, a DSPT, a clear intended purpose consistent with all marketing, evidence of benefit in NHS settings, a performance monitoring approach, safeguards against misuse, and integration with clinical systems, for example via IM1 in GP settings.

Sources

• NHS England: guidance on the use of AI-enabled ambient scribing products
• NHS England: ambient scribing
• NHS England: AVT self-certified supplier registry
• NHS England: information governance guidance for ambient scribing
• MHRA: ambient voice technology-enabled products (29 Jul 2026)
• MHRA press release: regulatory status of ambient voice technologies (29 Jul 2026)
• GOSH: AI scribe trial results (4 Sep 2025)