Regulation
EU MDR (Regulation 2017/745)
EU Medical Device Regulation — governs healthcare software that has a medical purpose.
Regulation (EU) 2017/745 (MDR) governs medical devices in the EU, including standalone medical-device software (MDSW). Software with a medical purpose of its own can be a regulated device under MDR, requiring CE marking, conformity assessment by a Notified Body, clinical evaluation, technical documentation and post-market surveillance.
The decisive classification rule for clinical-decision-support software is *Annex VIII, Rule 11* — see the dedicated entry.
See also
- MDCG 2019-11 — European Commission guidance on qualifying and classifying medical-device software under MDR.
- Annex VIII, Rule 11 (EU MDR) — The MDR rule that classifies decision-informing healthcare software as a regulated device.
- CE mark — Mark indicating an EU medical device has passed conformity assessment.
- Notified Body — Independent EU-designated organisation that audits regulated medical-device software.
- Class IIa medical device (MDR) — Moderate-risk MDR class — Notified Body assessment and CE mark required.