Regulation
Notified Body
Independent EU-designated organisation that audits regulated medical-device software.
A Notified Body is an independent organisation designated by an EU member state to perform conformity assessment on regulated medical devices, including software (Class IIa and above under MDR). Their involvement is required for CE marking at those classes.
See also
- CE mark — Mark indicating an EU medical device has passed conformity assessment.
- 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.