Short answer: A UK wellness assessment does not become a medical device merely because it uses software, collects health-related information or includes AI. The question is what the manufacturer intends it to do and what the product actually does. An assessment that claims to identify a disease, calculate an individual’s disease risk or guide a clinical decision needs a medical-device qualification review before those claims are used. A general wellbeing questionnaire and a clinical risk tool are not interchangeable simply because both appear on a screen.
The Medicines and Healthcare products Regulatory Agency (MHRA) explains that many software and AI products used in UK health and social care are regulated as medical devices or in vitro diagnostic devices. Its software guidance links to a specific qualification guide for standalone software and apps. That guide distinguishes medical purposes from functions such as monitoring fitness or wellbeing, storing or transmitting data without change, and purely administrative booking. It also describes software that gives an individual a percentage risk of having a disease as an example with a medical purpose. Those are examples for assessing a particular product, not an automatic verdict on every assessment platform.
Write down the actual intended purpose
For a buyer or operator, the first practical task is to request the supplier’s intended-purpose statement for the exact software version and configuration on offer. Ask what inputs it uses, what its output means, who is meant to read it and what action the user is expected to take. Review the website, sales deck, interface, report template and staff script together. MHRA’s intended-purpose guidance says the purpose is assessed using manufacturer information in labelling, instructions and promotional materials, as well as technical documentation. A cautious label cannot erase a contradictory diagnostic promise elsewhere in the customer journey.
If the output is a general lifestyle discussion prompt, describe it accurately and avoid adding disease language that the supplier has not substantiated. If the software is intended to detect a condition, monitor disease progression or influence referral or treatment, ask the manufacturer to explain its regulatory assessment and the evidence that supports that specific use. Do not assume that a human reviewing a report, or an AI feature being called a recommendation, removes the need for this assessment. The intended population, user and setting matter too: evidence for a trained clinician in a defined pathway does not automatically cover an untrained salon employee or a self-service customer.
Check the whole offer, not just the algorithm
MHRA’s March 2023 intended-purpose guidance identifies four elements to define for software as a medical device: structure and function, intended population, intended user and intended use environment. It warns that vague purposes make it harder to establish suitable evidence and that added functionality can move a previously non-medical product into medical-device territory. For an assessment service, a change from a neutral wellbeing summary to a named disease-risk score is therefore a material change to review before release. Likewise, adding a clinical module to a broader platform calls for a module-by-module explanation rather than relying on the platform’s original marketing category.
Ask for the manufacturer’s classification rationale, applicable conformity documentation, instructions, limitations, update policy and route for reporting problems. Check who is responsible for the report shown to customers and how staff are trained to explain uncertainty. These questions are especially important when a package combines hardware measurements, third-party software and a white-label report. The supplier should identify which party owns each claim and which version of each component was assessed. This is a procurement checklist, not a statement that any TUOKE product has a particular regulatory status.
The MHRA’s standalone-software guide states that it addresses software placed on the Great Britain market and that different rules apply in Northern Ireland. UK-wide sales plans therefore need location-specific review. The main software and AI collection was published on 6 April 2023 and last updated on 3 February 2025; the standalone-apps page was last updated on 1 July 2023. Buyers should check for subsequent changes before launch. This article is general UK market information, not legal or medical advice or a substitute for a product-specific determination.
TUOKE buyer perspective: Browse the wellness-assessment category to identify equipment to discuss, then request the exact model’s intended use, software scope and supporting documents. No diagnostic accuracy, clinical benefit or UK medical-device approval is implied by a category listing.
Sources
- MHRA, Medical devices: software and artificial intelligence (AI), published 6 April 2023, updated 3 February 2025; reviewed 8 October 2026.
- MHRA, Medical devices: software applications, published 8 August 2014, updated 1 July 2023; reviewed 8 October 2026. Its linked standalone-software PDF contains the qualification examples and the Great Britain/Northern Ireland distinction.
- MHRA, Crafting an intended purpose in the context of SaMD, published 22 March 2023; reviewed 8 October 2026.