Clinical safety and assurance
Is AI software a medical device in the UK?
It depends on the intended purpose. The MHRA says many software and AI products are regulated as medical devices, and a product is a device when its intended purpose is medical, such as diagnosis, prevention, monitoring or treatment of disease. Software that only performs administrative functions, or that just gives a clinician reference information to make their own decision, is unlikely to be a device.
Intended purpose decides
The MHRA's guidance on standalone software and NHS England's ambient scribing guidance (written with the MHRA) agree: whether a product qualifies depends on the intended purpose the manufacturer sets out in its instructions for use, labelling and promotional material. Small changes in how software is described can make the difference. A general disclaimer such as "this product is not a medical device" doesn't count if medical claims are made or implied elsewhere, and the manufacturer's own view isn't the only factor.
Where the MHRA's guidance draws the line
Unlikely to be a device:
- Software used to book appointments, request prescriptions or hold a virtual consultation, if it only has an administrative function.
- An electronic patient record that simply replaces a paper file.
- Software that stores or transmits medical data without changing it, or gives a clinician reference information to use their own knowledge.
- Decision support that reproduces a paper document, or explains options while the clinician decides which path to take.
Likely to be a device:
- Decision support that applies automated reasoning, such as a calculation or algorithm, for example dose calculations.
- Software intended to influence treatment (dose, timing) or that gives a diagnosis or prognosis.
The MHRA adds that software which performs a calculation, or interprets data the clinician doesn't review in raw form, may also be a device.
AI-specific guidance
The MHRA's Software Group covers software as a medical device (SaMD) and AI as a medical device (AIaMD). Its change programme roadmap, published on 17 October 2022, covers qualification and classification through to post-market requirements, plus AI-specific questions of transparency and adaptivity (retraining models). With the FDA and Health Canada, the MHRA has published guiding principles for good machine learning practice, predetermined change control plans and transparency.
What it means for a hospital buying AI
NHS England's ambient scribing guidance tells the people doing procurement due diligence to check that a product has been correctly considered under medical device regulation and, where applicable, is registered with the MHRA. Manufacturers of devices must run post-market surveillance and report serious incidents; deploying organisations are encouraged to report concerns through the Yellow Card scheme. Whether or not a product is a device, the DCB clinical safety standards still apply, and they never replace device regulation.
What it does not mean
- "AI" doesn't automatically make software a device. The intended purpose does.
- "Not a medical device" on the label doesn't settle it. The MHRA says such disclaimers don't count if medical claims are made or implied.
- Not being a device doesn't mean no safety work. DCB0129 and DCB0160 apply to health IT whether or not it's a device.
Where Thalix fits
The site describes the Thalix demo as not a medical device, and the design keeps it that way: agents draft, summarise, check and route work, and never make clinical decisions. Agents can never run or approve tier-3 actions (clinical decisions and orders); those exist only as signed, locked apps from a trusted publisher, and an order still needs a second person. If a hospital wanted Thalix to carry software with a medical purpose, its regulatory status would have to be settled first, with the publisher of that app and your own governance.
Thalix is at pilot stage. Demos run on synthetic data, and a hospital deployment needs its own clinical safety case, information governance approval and security review. We don't claim any certification or assessment result the product doesn't have.
Questions people ask
Is an electronic patient record a medical device?
The MHRA's guidance says an electronic patient record that simply replaces a patient's paper file doesn't meet the definition of a medical device.
Is clinical decision support software a medical device?
Often. The MHRA says decision support is usually a device when it applies automated reasoning such as a calculation or algorithm, but may not be if it only gives reference information for a clinician to decide with their own knowledge.
Does a disclaimer stop software being a medical device?
No. The MHRA says general disclaimers aren't acceptable if medical claims are made or implied elsewhere in the labelling or promotional material.
Sources
Each source below is an official page, read and checked in October 2026. Where a page and this guide differ, the official page wins.
- Medical devices: software applications (apps) MHRA, GOV.UK · checked October 2026
- Software and artificial intelligence (AI) as a medical device MHRA, GOV.UK · checked October 2026
- Crafting an intended purpose in the context of software as a medical device (SaMD) MHRA, GOV.UK · checked October 2026
- Guidance on the use of AI-enabled ambient scribing products in health and care settings NHS England · checked October 2026
- Applicability of DCB 0129 and DCB 0160: recommendation NHS England Digital · checked October 2026
General information only, written for hospital digital, IT, operations and clinical safety teams. It isn't legal, regulatory, information governance or clinical safety advice, and it doesn't replace your own organisation's processes or the official guidance linked above.