Is my software a medical device under EU MDR?

In short: Your software is a medical device under EU MDR if it has a medical purpose: diagnosing, preventing, monitoring, predicting, or treating disease, or informing such decisions. Pure wellness, fitness, or administrative software is out of scope — but the boundary is set by your intended purpose and marketing claims, not your technology.

Purpose, not technology, sets the boundary

MDR's test, as set out in the Medical Device Coordination Group's guidance (MDCG 2019-11 rev.1), asks two things: does the software do something with data beyond storing, archiving, communicating, or simply searching it, and is that action intended for the benefit of an individual patient, for a medical purpose defined in MDR Article 2(1)? A tool that calculates a risk score used in a treatment decision clears both tests. A tool that stores and displays lab results without interpretation clears neither. Clearing both settles only that you have a device — which class it falls into is the separate next step, under Annex VIII.

This is why identical underlying code can sit on either side of the line. A heart-rate app that says "track your heart rate during exercise" is wellness. The same sensor data, packaged as "detect signs of atrial fibrillation," is a device candidate — and depending on the clinical significance of a missed detection, likely Class IIa or higher under Rule 11.

Why the claims audit matters as much as the code

Regulators and courts read the totality of what you communicate — landing pages, app store listings, investor decks, social posts — not just your formal instructions for use. One unguarded disease-adjacent claim can pull an otherwise wellness product into device territory, regardless of what your terms of service say. Labelling a genuine clinical decision-support tool as "wellness" to avoid MDR doesn't change its legal status; it only changes whether you've complied with obligations that already apply, which is a worse position to discover during due diligence or a Notified Body audit than starting the classification conversation now.

A live European Commission proposal (December 2025, not yet law) would revise Rule 11 to let more software land in Class I or IIa — see What is MDR Rule 11, and why does it make my software Class IIa? for the current status.

Where next: MDR Rule 11: Why Software Lands in Class IIa · What is MDR Rule 11, and why does it make my software Class IIa?

Find out in minutes where your product likely sits. Start the MedTech Compass → — AI-generated first read, not a validated determination.