Is your health or care app a medical device?

If an app is a medical device, it has to meet the UK Medical Devices Regulations 2002 before it is used: conformity marking, registration with the MHRA, and post-market surveillance. Those surveillance duties were strengthened by new regulations that came into force on 16 June 2025. If it is not a medical device, none of that applies. So it is worth knowing which side of the line a product is on before you buy or build it, not after.

It starts with the intended purpose

Whether software is a medical device depends on what it is for, as stated by whoever makes it, and on what it actually does. MHRA guidance is clear that a medical purpose is judged from the product’s labelling, instructions and promotional material. That includes the website, the app store description and category, adverts and the maker’s social media.

Two consequences catch people out. First, small changes in wording can move a product across the line. Second, a disclaimer saying “this is not a medical device” does not help if medical claims are made or implied anywhere else, including in testimonials the maker repeats.

What usually is, and is not, a medical device

Generally not medical devices:

• information, advice and signposting to services
• booking, reminders and communication tools that pass data on unchanged
• apps that store or display information without changing it
• self-assessment forms that a professional reviews and acts on

Can be medical devices:

• software that diagnoses, predicts, monitors or recommends treatment for an individual
• calculations a user cannot easily check, such as risk scores
• AI that processes a person’s data for a medical purpose

The MHRA’s test for mental health technology

For digital mental health technology, the MHRA has published a specific test, most recently updated to version 1.3 on 29 July 2026. A product is a medical device if it has a medical purpose and high functionality. Low functionality means it only stores data, passes data on unchanged, shows fixed content, or does a calculation that is easy to check. High functionality means interactive or personalised output, a calculation that is not easily checked, or processing with AI.

That test is written for mental health technology only. In our view it is still a useful way to think about other health and care software, but it does not replace the general MHRA guidance on stand-alone software.

If it is a medical device: CE and UKCA marks

Great Britain still accepts CE-marked devices for now. Devices certified under the older EU directives are accepted until their certificate expires or 30 June 2028, whichever comes first. Devices certified under the newer EU regulations are accepted until 30 June 2030. The MHRA consulted between February and April 2026 on recognising CE marks indefinitely, but at the time of writing it had not published the outcome.

What commissioners should ask for

• A written intended purpose statement for the product.
• A check that the website, app store listing and marketing say the same thing as that statement.
• If the maker says it is a medical device: its class, its UKCA or CE marking, and its MHRA registration.
• If the maker says it is not: their reasoning, and a commitment to tell you before adding features that could change the answer.
• Clinical safety evidence either way, which you will need for DTAC (see DTAC explained).

We carry out fixed-scope medical device and DTAC triage for councils and NHS teams, and design our own products, such as Striova, to stay non-diagnostic.

Sources

• MHRA: Medical device stand-alone software including apps
• MHRA: Digital mental health technology – qualification and classification (v1.3, July 2026)
• MHRA: Crafting an intended purpose for software as a medical device
• MHRA: Timelines for acceptance of CE-marked medical devices in Great Britain
• MHRA: Consultation on indefinite recognition of CE-marked devices
• MHRA: Post-market surveillance requirements

This article is general guidance, correct as of the date shown. It is not legal advice. Rules and frameworks change, so check the sources before relying on it.