Regulation
Class IIa medical device (MDR)
Moderate-risk MDR class — Notified Body assessment and CE mark required.
Class IIa is the moderate-risk MDR classification. It requires Notified Body involvement in conformity assessment, CE marking, a clinical evaluation, technical documentation and post-market surveillance. Software that informs diagnostic or therapeutic decisions starts at Class IIa under Annex VIII Rule 11.
Related tools
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.
- Notified Body — Independent EU-designated organisation that audits regulated medical-device software.
- CE mark — Mark indicating an EU medical device has passed conformity assessment.