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.
- 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
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Unit for medical devices - development and notified body
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