Last updated: 31 July 2026
The MHRA has significantly narrowed what counts as a medical device in UK ambient voice technology (AVT). Under new guidance published on 29 July 2026, tools that only transcribe, summarise, structure, or draft documentation from a clinical conversation — with a clinician reviewing the output — are not regulated as medical devices. NHS England adopted the guidance immediately, reversing the much broader stance it took in April 2025.
Background — How We Got Here
NHS England's April 2025 Guidance
On 27th April 2025, NHS England released a guidance document titled “Guidance on the use of AI-enabled ambient scribing products in health and care settings.” The guidance and advice were well-intentioned — bringing together clear direction on how NHS organisations (and by extension suppliers) could ensure their products were safe and secure to meet the expectations of the NHS in England.
The Regulatory Grey Area It Created
In a highly unusual move, NHS England also decided to dabble in medical device regulatory guidance — an area reserved to the MHRA in the UK — and created a maelstrom of confusion about what was and was not considered a medical device, including any processing of any type beyond simple transcription. Well-established technologies used for years within the NHS were declared non-compliant with NHS requirements overnight, as the guidance had no pre-warning and no implementation period for suppliers to respond.
How Suppliers Responded Under Pressure
Suppliers who noticed — as NHS England did not notify suppliers of this guidance directly — had to respond quickly, rushing to implement quality management systems, create technical files, and register with the MHRA. This rapid implementation of Medical Device quality and safety controls led numerous NHS leaders and industry commenters to question the quality of the controls. As a result, this undermined the accepted trust that historically has come with being a Medical Device and led some to call for the end of self-certification of medical devices in the UK.
The New MHRA Guidance, Explained
Thankfully the MHRA has published guidance on ambient voice technology-enabled products that significantly narrows the scope of what counts as a medical device. The guidance was developed jointly with NHS England, with input from clinicians, technologists, and patient safety advocates.
What's Not a Medical Device
AVT products used for the following are not regulated as medical devices:
- summarising a patient interaction
- structuring interaction data
- suggesting clinical codes
- drafting letters
What's Still Regulated as a Medical Device
The guidance draws the line at clinical decision-making and unsupervised action. A product is still regulated as a medical device if it suggests diagnoses or treatments, or if it takes automated action such as placing an order or triggering a referral — without a clinician reviewing it first. The principle isn’t “AI in healthcare is exempt”; it’s that tools which only document and organise information, with a clinician in the loop for every clinical decision, fall outside the medical device definition.
NHS England's Immediate Adoption of the Guidance
This new guidance was immediately adopted by the NHS, avoiding a confusing conflict between the two organisations. The guidance gives no explicit instruction to organisations that registered solely based on the previous NHS guidance — however these could be de-registered from the MHRA DORS platform if you’re confident no medical device features are remaining under this new guidance.
What This Means for AVT Suppliers and NHS Trusts
For Suppliers Who Already Registered
If you registered as a medical device under pressure from the April 2025 NHS mandate, the new guidance doesn’t force a reversal but if your product only performs the now-exempt functions (summarising, structuring, coding suggestions, drafting), there’s a route to de-register. However, we still think there are benefits to being a medical device including increased user trust, positive investor news and an easier procurement process – especially while this guidance rolls out to NHS Procurement Teams
For Suppliers Who Held Off
If you delayed or avoided certification while the picture was unclear, this guidance gives you a much firmer footing — provided your product genuinely stays within the documentation-only definition.
For NHS Procurement Teams
The AVT registry has relaxed its requirements for all AVT suppliers to provide a declaration of conformity, so don’t expect all of them to provide one; you’ll need to confirm whether the functionality of the software reaches the level of a medical device and check the Regulatory Strategy of your suppliers to confirm they’ve made the correct decision.
How the UK Approach Compares — EU and US
The regulatory position of AVTs in the EU is even more muddled than in the UK – compounded by four key factors.
Despite legally being part of the United Kingdom, Medical Devices released onto the Northern Ireland market must follow EU rules under the Windsor Agreement – for Medical Devices, you have to treat Northern Ireland as part of the EU, despite legally being part of the United Kingdom
- The argument that has been raging for almost a decade now about whether it is possible to create a class I SaMD in the EU.
- A recent ruling from the Court of Justice of the European Union finding that simply claiming improved patient outcomes does not make your product a medical device.
- Unpublished and unconfirmed findings on risk classification of AVTs by the Swedish Medical Device Regulator.
- Proposed changes to the EU Medical Device Regulations themselves.
AVTs in the EU are being marketed as not medical devices, Class I and Class IIa, and classification is heavily dependent on the exact features of the product and the requirements of customers – we’ve also had reports of some healthcare systems requiring medical device certification.
Of course, medical device regulations are not the only regulations applicable to AVTs in the EU; the EU AI Act will affect Class IIa and higher AI-enabled medical devices – including AVTs – from August 2028.
Our Take — What This Reveals About UK MedTech Regulation
All regulations are a balancing act between product safety and product access. Under-regulation of medical devices leaves patients and clinicians using unsafe products and causes harm to patients, but over-regulation leaves clinicians without the tools they need to provide care.
The MHRA and NHS share the blame for this debacle.
The MHRA has failed to provide clear guidance on the appropriate regulation of medical devices containing artificial intelligence, despite AI-enabled medical devices having been on the UK market for more than a decade. The NHS bumbled into a complicated area with much too broad a brush, causing confusion and no small amount of panic among suppliers.
Clear outcomes from the MHRA’s AI commission can’t come soon enough.
Frequently Asked Questions.
Is an ambient scribe a medical device in the UK?
Not automatically. Under the MHRA's July 2026 guidance, tools that only transcribe, summarise, structure, or draft documentation — with a clinician reviewing the output — are not regulated as medical devices.
What is ambient voice technology (AVT)?
Ambient voice technology uses microphones and speech recognition to capture a clinical conversation and turn it into structured documentation, such as notes, letters, or coded entries, without the clinician needing to type.
Do AI scribes need to register with the MHRA?
Only if they go beyond documentation — for example, suggesting diagnosis or treatment decisions, or taking automated action without clinician review. Purely documentation-focused tools do not need MHRA medical device registration under the new guidance.
What NHS registry do AVT suppliers need to be on?
The existing AVT registry remains in effect for suppliers wanting to provide AVT to the NHS, but there is no longer a requirement to provide evidence of registration with the MHRA for all products.
Building an AI Medical Device?
Speak to a member of our team today to understand the latest guidance and how we can support you to comply with international Medical Device regulations.
