A wellbeing claim on the website, a medical claim on the feed
- Example 6 of the MHRA guidance on digital mental health technology describes a product whose website says it supports wellbeing, while the manufacturer's social media promotes it as reducing the risk of developing depression and / or the app is regularly recommended by healthcare professionals in primary care for moderate depression. The document writes those two as and / or, so either branch on its own carries the finding. The agency offers two routes and no third: regulate the product as a medical device, with consistent messaging around its intended use and evidence, or remove the inferences to mental health conditions everywhere and ensure the product is not recommended by healthcare professionals or used for a medical purpose.
- Qualification as software as a medical device runs two tests and both have to be met: whether the product has a medical purpose, and whether it has sufficient functionality. Medical purpose is read from labelling, instructions for use and promotional materials, which the document spells out as website, social media and adverts. Two further markers count on their own: the product carries a standardised measure such as PHQ-9 or GAD-7 and lets a user carry on whatever the score, or it is used or recommended as part of an NHS service.
- Table 3 numbers 29 example functions. Function 26 collects passive smart-watch data – sleep, activity levels, breathing rate, heart rate variability – together with answers the user types in, and recommends interventions such as exercise, sleep hygiene or socialising. It is marked High functionality. Function 25 asks three basic questions and returns a recommendation the user can trace back to the answer, and is marked Low. Heart rate variability sits there as an input to software, not as an outcome anybody measured.
- The document was published on 3 February 2025 and revised to version 1.3 on 29 July 2026. It applies to digital mental health technologies placed on the UK market, Great Britain and Northern Ireland, including direct-to-consumer products bought from app stores. It is guidance: the obligation it explains sits in the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended), and the guidance carries no penalty, inspection procedure or deadline of its own.
Example 6 of the guidance sets a website against a social media account. On the website the product is designed to support individuals to improve their well-being. On the feed the same product is promoted as reducing the risk of developing depression, and / or the app is regularly recommended by healthcare professionals in primary care to help those with moderate depression. Nothing in the software differs between the website and the feed. The MHRA reads them together and gives the manufacturer two routes: regulate the product as a medical device, with consistent messaging around its intended use and evidence behind it, or remove the inferences to mental health conditions on social media and elsewhere and ensure it is neither recommended by healthcare professionals nor used for a medical purpose.
Purpose and functionality
Qualification turns on two questions and a product has to answer yes to both. Does it have a medical purpose? Does it have sufficient functionality? The first question is about claims, the second about what the software does with data. Computational tasks are sorted into seven categories, A to G, and a calculation counts as easily verifiable only when six conditions are all met, the last of them a user study showing that a typical user can detect a wrong score and check it without a calculator.
Where the agency looks for the claim
Intended purpose is not read off the product page alone. The guidance names labelling, instructions for use and promotional materials, then spells the last of those out as website, social media and adverts. A note attached to the table on medical purpose adds two markers with no wording in them at all. One: the product carries a standardised measure such as PHQ-9 or GAD-7 and individuals with all scores can continue to use it. Two: it is used or recommended as part of an NHS service.
The list stops at the NHS, and Example 6 carries the point past it: there a recommendation by primary care staff for moderate depression is one of the branches that can pull the product under regulation. A clinician who suggests a breathing app or a heart-rate app supplies one of the facts the agency reads when it decides whether the product needed a conformity assessment. The manufacturer writes the intended purpose; clinical use of the product can contradict what was written.
Function 25 against function 26
Table 3 works through 29 example functions and marks each as low or high functionality. Function 26 takes passive data from a smart watch – sleep, activity levels, breathing rate, heart rate variability – alongside answers typed in by the user, processes them with a calculation the document classes as not easily verifiable, and recommends exercise, sleep hygiene or socialising. High. Function 25 asks three basic questions about how someone is feeling and returns a suggestion the user can trace back to the answer given. Low. The mark does not follow the sensor. Function 26 is high because the document classes its calculation as not easily verifiable, and function 25 is low because the user can follow the step from the answer given to the suggestion returned. Traceability draws that line, and the heart-rate stream crosses it through the calculation it feeds rather than on its own.
Guidance, not rule
The document says where the obligation lives. In Great Britain UKCA certification rests on compliance with the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended); in Northern Ireland CE certification rests on the EU MDR. Classification follows: class I products self-certify and register with the MHRA, class IIa and above need approval from an approved or notified body.
The website says wellbeing and the feed says the product reduces the risk of depression, and the MHRA reads both when deciding whether that product is a medical device.
This is guidance rather than legislation. It carries no penalty, no inspection procedure and no deadline, and the obligation it explains sits in the UK Medical Devices Regulations 2002 and, for Northern Ireland, the EU MDR. It is not a decision about any named product, and no manufacturer, app or device is identified anywhere in it. Heart rate variability appears once, as an example input in an illustrative table of 29 functions, and function numbers are MHRA teaching examples rather than counts of products or companies. The 54 pages and 866 kilobytes measure the file, not a market: the document prints no market size, no number of products, no share of apps outside regulation, and no such figure should be attached to it. Classification here is about risk and about how verifiable a calculation is, not about whether any intervention changes a clinical outcome; the document reports no protocol, no sample, no outcome and no control group, because it is not a study. It covers the UK market and says nothing about other jurisdictions. The guidance was produced by the MHRA under Crown copyright within a Wellcome-funded project run in partnership with NICE, which the document states in its own section on development.