Regulation
MDCG 2019-11
European Commission guidance on qualifying and classifying medical-device software under MDR.
MDCG 2019-11 is the European Commission's official guidance document for qualifying and classifying medical-device software under MDR. It contains the stepwise decision tree used to decide whether a piece of software is a medical device, and if so, which class.
Revision 1 was published in June 2025. Any vendor making MDR claims should reference current MDCG guidance.
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- Annex VIII, Rule 11 (EU MDR) — The MDR rule that classifies decision-informing healthcare software as a regulated device.