Skip to content Norwegian Medical Products Agency Norwegian Medical Products Agency

Performance studies which require a notification

Published:

Changes

Information regarding performance studies which require a notification to NOMA. This includes PMPF studies as described in IVDR article 70 (1), and studies involving companion diagnostics (CDx) where only left-over samples are used. 

Contact us

Unit for medical devices - development and notified body

(+47) 22 89 77 00

Questions regarding clinical trials, classification and innovation guidance

kki@noma.no