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

Published: 05/10/2023

Changes

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.

Introduction to performance studies of IVD medical devices
Performance studies which require an application
Performance studies which require a notification
Other performance studies
Combined studies
Safety reporting in performance studies
Substantial modifications to a performance study
End or temporary halt of a performance study

Did you find what you were looking for?

Describe what you did not find

0/255 characters

I confirm that I do not submit any personal information, e.g. name, telephone number or email address.