Regulation
CE mark
Mark indicating an EU medical device has passed conformity assessment.
The CE mark indicates that a product — including a regulated medical-device software — has passed the conformity assessment required by EU regulation. For Class IIa and above under MDR, the assessment is done by a Notified Body and the mark requires ongoing post-market surveillance.
Several European scribes lead with CE / EU MDR status (Tandem Health, Haidy / 44ai, Stenoly).
Related tools
See also
- EU MDR (Regulation 2017/745) — EU Medical Device Regulation — governs healthcare software that has a medical purpose.
- Notified Body — Independent EU-designated organisation that audits regulated medical-device software.
- Annex VIII, Rule 11 (EU MDR) — The MDR rule that classifies decision-informing healthcare software as a regulated device.