How to Know If Your Software Is a Medical Device

The short answer

Under Article 2 of MDR 2017/745, software is a medical device when its manufacturer intends it for a medical purpose, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Software that only stores, moves or searches data, or that supports general wellness, is generally not a medical device. The deciding factor is the intended purpose and the claims you make, not the underlying technology.

Work through it step by step

1. Write down your intended purpose. Describe, in plain terms, what your software does, who it is for and what you claim it achieves. This statement of intended purpose drives everything that follows, so be specific and honest about the claims you make to users.
2. Check whether it does more than store, move or search data. Software that only stores, archives, communicates or runs a simple search is generally not a medical device. If your software instead interprets, calculates, analyses or supports a decision about a person, keep going.
3. Look for a medical purpose. Match your intended purpose against the MDR medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, and investigation or modification of a physiological process. If one clearly fits, your software points towards being a medical device.
4. Separate wellness from medical claims. General wellbeing, fitness and lifestyle tools are usually outside the MDR. Software that detects, diagnoses or monitors a condition, or informs a clinical decision, is usually inside it. What you claim decides the outcome, so an accidental medical claim can pull a wellness app into scope.
5. Check the edge cases. Watch for software split into modules (only the medical-purpose modules are regulated, and they should be separable), software that drives or influences a hardware device (which can make it an accessory), and AI or machine-learning features (which get no special exemption).
6. If it is a medical device, classify it and sanity-check. Once you conclude it qualifies, work out its risk class and get a second opinion on borderline calls from a consultant, your notified body or the competent authority.

If the last step applies to you, classification comes next. See our SaMD classification guide for how Rule 11 assigns a class, and the MDR classification guide for the wider set of rules.

A quick self-check

• Have you written a clear statement of intended purpose?
• Does the software do more than store, move or search data?
• Does it serve one of the MDR medical purposes?
• Are your claims medical rather than general wellness?
• Have you checked modules, accessories and AI features?

Answering yes to the middle three points strongly suggests your software is in scope and needs to be classified.

Frequently asked questions

Is my app a medical device?

It depends on what you intend the app to do. If it diagnoses, monitors or treats a condition, or informs a clinical decision, it is likely a medical device under the EU MDR. If it only supports general wellness, fitness or administration, it usually is not. The intended purpose and the claims you make decide it, not the technology.

Does software need a medical purpose to be regulated?

Yes. Qualification hinges on an intended medical purpose, and on the software doing something with data beyond storing, communicating or simply searching it. Software with no medical purpose is generally outside the MDR.

Are wellness and fitness apps medical devices?

Usually not. A step counter or general fitness tracker is wellness, not a medical device. But the moment an app claims to detect, diagnose or monitor a specific condition, it can become a medical device, because the medical claim changes its intended purpose.

Is AI or machine-learning software automatically a medical device?

No. AI gets no special status. AI software qualifies as a medical device on the same intended-purpose test as any other software, and if it qualifies it is then classified under Rule 11.

What guidance should I follow to decide?

Use the medical device definition in Article 2 of MDR 2017/745, together with the MDCG 2019-11 guidance on qualification and classification of software. Treat your own assessment as preparatory and confirm borderline cases with a notified body or competent authority.