Regulation
Annex VIII, Rule 11 (EU MDR)
The MDR rule that classifies decision-informing healthcare software as a regulated device.
Annex VIII, Rule 11 of MDR is the classification rule for clinical-decision-support software. The official text states that software intended to provide information used to take decisions with diagnostic or therapeutic purposes is classified *at minimum Class IIa*, escalating to IIb or III as the potential for patient harm increases.
This is why a US-born clinical-decision tool can't trivially launch in the EU — Rule 11 places it on a regulated path that includes Notified Body assessment, CE marking, clinical evaluation and post-market surveillance.
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- MDCG 2019-11 — European Commission guidance on qualifying and classifying medical-device software under MDR.
- CE mark — Mark indicating an EU medical device has passed conformity assessment.
- Class IIa medical device (MDR) — Moderate-risk MDR class — Notified Body assessment and CE mark required.