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Performance studies of in vitro-diagnostic (IVD) medical devices

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Before starting a performance study, the sponsor must determine if the study requires an application or a notification to the Norwegian Medical Products Agency (NOMA).

​​​​​​​​​​​​​​​​​​​​​​​​Below you can find information on performance studies, including how to submit applications and notifications. You can also find information on safety reporting, substantial modifications and termination of the performance study. 

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