Summary
In the NHS this is not a preference question. Any ambient tool that summarises a consultation must be registered as at least an MHRA Class I medical device, and anything generating diagnoses or management plans needs Class IIa.2 Non-compliant products are not permitted, free trials included, and the liability sits with your practice rather than the vendor.1
Check the MHRA public register and the NHS England AVT Supplier Registry before you let any product near a patient. That includes us.
Ask us for our registration status before you ask us anything else.
Book a demoWhat the NHS actually requires
NHS England published guidance on ambient scribing in April 2025 and updated it in April 2026. A priority notification from the Chief Clinical Information Officer in June 2025 tightened it and told organisations to pause non-compliant deployments immediately.11NHS England, Guidance on AI-enabled ambient scribing products. April 2025, Version 2 April 2026.
A tool that only transcribes may not be a medical device. A tool that summarises almost certainly is, and NHS England requires at least Class I registration for those.22NHS England Chief Clinical Information Officer priority notification, 9 June 2025. Summarisation requires at least MHRA Class I. Diagnoses or management plans require Class IIa. A tool that proposes a diagnosis or a management plan needs Class IIa, which is a different bar entirely.
The rest of it runs deeper. Your supplier owes you a DCB0129. You complete a local DCB0160, which includes a DPIA and a clinical safety case, and you appoint a Clinical Safety Officer. DTAC and DSPT checks. Cyber Essentials Plus. The AVT Supplier Registry opened in January 2026 and wants Class I registration plus a current DTAC, and DTAC itself was refreshed in February 2026 with a transition deadline of 6 April.33NHS England AVT Supplier Registry, launched January 2026. Requires Class I registration and a current DTAC. Applications reopened February 2026. DTAC refreshed February 2026, transition deadline 6 April 2026. Wales published parallel guidance in August 2025.
Registered is not certified
These two words get used as though they mean the same thing and they do not.44MHRA public device register. Registration is mandatory for all devices. Certification by an Approved Body is required at Class IIa and above. Registered means listed with the MHRA, which every device must be, and at Class I a manufacturer can self-declare with no external assessment. Certified means an independent UK Approved Body has looked at it, which is mandatory at Class IIa and above.
TORTUS became the first AVT certified UKCA Class IIa on 24 June 2026, assessed by Scarlet. Tandem holds EU MDR Class IIa, CE marked, which Great Britain accepts until 30 June 2028, and its Coding Assistant was the first in its category in Europe at that class. Heidi is reported as self-declared Class I with Class IIa in progress.55Regulatory status as reported July 2026. TORTUS UKCA Class IIa, Scarlet, UK Approved Body 8536, 24 June 2026. Tandem Health EU MDR Class IIa, CE marked. Heidi self-declared Class I. Verify against the MHRA public register. Microsoft DAX Copilot is widely sold and UK organisations should verify its specific UK device status before deploying it.
When a vendor tells you they are compliant, ask which product, which feature, which regime, which class, and who assessed it. Then check the MHRA register yourself rather than taking the answer.
Consent works differently here
Explicit patient consent is not legally required for an ambient scribe used in individual care in England. Transparency is, and you must tell the patient at the start of the session. NHS England publishes wording you can adapt.66NHS England information governance guidance, reviewed by the ICO and National Data Guardian, with template DPIA, March 2026. That is close to the opposite of the United States, where sixteen states require consent from every person in the room and some carry criminal exposure for the clinician. If you practise in both, our guide to consent covers the US position.
Audio and transcripts should be deleted once a verified summary exists, unless you have a clear justification for keeping them. You retain full responsibility for the accuracy of the record, and outputs must be checked and corrected before they are saved.
What is already there
Accurx and Tandem partnered to put Accurx Scribe in front of more than 200,000 NHS staff, and Accurx already sits in about 98 percent of GP practices in England.88Accurx and Tandem Health partnership, reported May 2026. Accurx is present in approximately 98 percent of GP practices in England. Distribution on that scale is not something a standalone product competes with directly, and we are not going to pretend otherwise.
The evidence is better here than in the US literature. An NHS England sponsored study reported a 23.5 percent increase in direct patient interaction time and an 8.2 percent reduction in appointment length.77NHS England sponsored study. 23.5 percent increase in direct patient interaction time, 8.2 percent reduction in appointment length. England recorded approximately 35 million GP appointments in March 2026. Against 35 million GP appointments in March 2026 alone, those percentages are large.
How to check us, and everyone else
Do not take a vendor's word for this, including ours. Two places settle it. The MHRA public register, and the NHS England AVT Supplier Registry, which lists self-certified suppliers and requires at least Class I registration plus a current DTAC.
Ask any vendor, us included, four things and make them answer in writing. Which legal entity holds the registration, because brand and manufacturer names frequently differ and that breaks traceability. Which product and which feature is covered. Under which regime and at which class. And who assessed it, or whether it is self-declared.
Then check the answer against the register yourself. A survey of 121 AI scribe products found only 7 percent explicitly claimed Class I status, and of those only six could be definitively located on the MHRA register under the same or a clearly linked legal entity.99Kaczmarek K, et al. Trust Me, I Might be a Medical Device, The Problem with AI Scribes. Research Square, preprint, March 2026. Survey of 121 AI scribe products. Ninety-three percent of this market does not make the claim at all. NHS England requires it for any tool that summarises, and the liability for deploying one that does not have it is yours.
WA\ Clinician answers clinical questions with citations from current guidance, and a tool that informs a management plan sits at Class IIa rather than Class I. Ask us where we sit on that line and hold us to the answer in writing, the same as you would hold Heidi, Tandem or TORTUS.
What we are not claiming
We are not telling you we are the best option for an NHS practice today. If we are not on the registry when you read this, we are not an option for you at all, and Tandem through Accurx, TORTUS at Class IIa, or Heidi are where you should be looking.
This is general information rather than regulatory advice. The rules moved three times in eighteen months and they will move again.
Availability
Pricing is on one page. If you are an NHS organisation, ask us for our registration status before you ask us for anything else.
Frequently asked questions
Which AI scribes are approved for NHS use?
NHS England requires any ambient voice technology performing clinical summarisation to hold at least MHRA Class I registration and a current DTAC assessment, and lists self-certified suppliers on the AVT Supplier Registry launched in January 2026. TORTUS became the first AVT certified UKCA Class IIa on 24 June 2026, assessed by Scarlet. Tandem Health holds EU MDR Class IIa, CE marked and accepted in Great Britain until 30 June 2028, and powers Accurx Scribe across more than 200,000 NHS staff. Heidi is reported as self-declared Class I with Class IIa in progress. Verify any status against the MHRA public register rather than vendor marketing.
What is the difference between MHRA registered and MHRA certified?
Registered means listed with the MHRA, which every medical device must be, and at Class I a manufacturer can self-declare with no external assessment. Certified means an independent UK Approved Body has assessed the device, which is mandatory at Class IIa and above. Registration alone is not certification, and vendors use the words interchangeably in marketing. Ask which product, which feature, which regime, which class and who assessed it, then check the MHRA public register yourself.
Do I need patient consent for an AI scribe in the NHS?
Explicit consent is not legally required for an ambient scribe used in individual care in England, but transparency is essential and you must tell the patient at the start of the session. NHS England publishes wording you can adapt, and information governance guidance reviewed by the ICO and National Data Guardian was published with a template DPIA in March 2026. This is close to the opposite of the United States, where sixteen states require consent from every person in the room. You retain full responsibility for the accuracy of the record and outputs must be checked before saving.
Ask us for the registration first.
If we are not on the AVT Supplier Registry when you read this, we are not an option for you and we will say so.
About this article. Written and published by WA\, which sells an ambient documentation product and is therefore describing a regulatory bar it has to clear itself. Every requirement here is cited to NHS England, the MHRA or the AVT Supplier Registry in the margin and was current at the updated date above. Regulatory status for every product named changes quickly, particularly as tools move from Class I toward Class IIa. Verify against the MHRA public register and the AVT Supplier Registry before procuring anything, including ours. This is general information and not regulatory or legal advice. All names are marks belonging to their owners.