Guides

Regulation, plain English.

Practical guides for software founders navigating EU MDR, SaMD classification, and QMS compliance. No jargon, no consultant-speak.

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Is my software a medical device?

The complete guide to how EU MDR decides whether your app is regulated -- and what to do if the answer is yes. Covers the two tests that determine everything, what is always exempt, and the grey zones most founders land in.

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By app type

Usually not regulated

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 claims

Is 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 regulated

Is 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 output

Is an AI health app a medical device?

The technology is irrelevant. What determines classification is whether the AI output influences a clinical decision.

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