Guide
Is my software a medical device?
A plain-English guide for software founders on how EU MDR actually decides, and what to do when the answer is yes.
References: EU MDR 2017/745 · MDCG 2019-11
General information only. This guide does not constitute legal, regulatory, or professional advice. Regulatory classification depends on the specific facts of your product, your intended market, and how your software is described and used. Rules change, and the information here may not reflect the most current guidance. If you are unsure whether your software is a medical device, seek advice from a qualified regulatory consultant or legal professional before making any compliance decisions. QualiHQ makes no representations about the accuracy or completeness of this content and accepts no liability for any decision made in reliance on it.
The short answer
It depends on two things: what your software does, and what you say it does.
EU MDR does not care that you are a startup, that you added a disclaimer, or that the AI made the decision. It cares about intended purpose: does your software produce outputs that influence medical decisions about individual patients? If yes, you are a medical device. If no, you are not.
The two tests that determine everything
Intended purpose: what does your software actually do?
Does it take patient-specific data as input and produce an output that influences a medical decision? Diagnosis, treatment selection, disease monitoring, risk prediction for individual patients -- these are all medical purposes. Storing data, searching records, scheduling appointments, or displaying raw numbers without clinical interpretation are not.
Medical purpose
- → Detect, diagnose, or screen a condition
- → Recommend a treatment or drug
- → Monitor the progress of a disease
- → Predict an individual patient outcome
- → Triage patients into care pathways
Not a medical purpose
- → Store or retrieve health records
- → Schedule appointments
- → Display raw measurements without interpretation
- → Handle billing, coding, or admin
- → Provide general health information
Claims: what do you say it does?
Regulators determine intended purpose from your marketing, your documentation, your onboarding flow, and any reasonably foreseeable use. Two apps with identical code can sit on opposite sides of the line based solely on what the manufacturer claims.
A fitness tracker that says "see your heart rate" is not a medical device. A fitness tracker that says "detects atrial fibrillation" is. Same hardware, same sensor -- different intended purpose because of different claims.
What is always outside scope
MDCG 2019-11 Appendix IX lists software that is categorically not a medical device regardless of context:
The grey zone most founders land in
Most products that end up regulated did not start there. They added features, changed their marketing, or got used in ways they did not anticipate. The shifts that most often tip apps into device territory:
Scenarios
How the rules apply to specific app types.
Is a fitness tracker a medical device?
Most fitness trackers are not. The line is drawn at clinical claims, not at measuring health data.
Depends on your claimsIs a mental health app a medical device?
Mental health apps live in a grey zone. What you say about your app matters more than what it actually does.
Very likely regulatedIs a symptom checker a medical device?
If your app takes symptoms and produces a diagnosis or triage recommendation, the answer is almost certainly yes.
Usually regulated if clinical outputIs an AI health app a medical device?
The technology is irrelevant. What determines classification is whether the AI output influences a clinical decision.
Free tool
Not sure about your specific app?
Answer five questions about what your app actually does. The tool gives you a read in two minutes -- not legal advice, but a clear sense of which side of the line you are on and what to think about next.
If the answer is yes, QualiHQ gives you the infrastructure to build your QMS, capture your software development evidence, and prepare your technical file -- without a consultant for every step.
Common questions
What is Software as a Medical Device (SaMD)?
Software as a Medical Device (SaMD) is software intended to be used for one or more medical purposes without being part of a hardware medical device. The term comes from IMDRF guidance and is used by regulators worldwide including the EU (MDR), US (FDA), and UK (MHRA).
What software is always exempt from EU MDR?
Software intended only to store, archive, communicate, or retrieve data is not a medical device. Administrative software (scheduling, billing, coding), general-purpose software, and software for research that is not used for individual patient decisions are also outside scope. This is defined in MDCG 2019-11.
Does adding a disclaimer stop my app from being a medical device?
No. Regulators look at intended purpose, which is determined by your marketing, labelling, and any reasonably foreseeable use -- not by disclaimer text. If your app produces a clinical output (diagnosis, triage, treatment recommendation), it is a medical device regardless of what disclaimers you include.
What is the MDCG 2019-11 guidance?
MDCG 2019-11 is the EU Medical Device Coordination Group guidance on software qualification and classification under EU MDR and IVDR. It includes a decision flowchart for determining whether software is a medical device and how it should be classified. It is the primary reference document for software manufacturers targeting EU markets.
If my app is a medical device, what do I need?
At minimum: a Quality Management System (QMS) meeting ISO 13485, a software development lifecycle process meeting IEC 62304, a technical file, clinical evaluation, and conformity assessment by a notified body (for Class IIa and above). The scope of work depends on your device classification. Getting your QMS in place early is the highest-leverage thing you can do before approaching a notified body. QualiHQ is built to help software teams do exactly that -- generating your QMS documentation, tracking requirements and test evidence, and managing release approvals without a consultant for every step.