Clinical investigation of medical devices
Published:
Changes
Before starting a clinical investigation of a medical device, the sponsor must determine if the investigation requires an application or notification to the Norwegian Medical Products Agency (NOMA).
Below you can find information on clinical investigations, including how to submit applications and notifications. You can also find information on safety reporting, substantial modifications and termination of the investigation.
- Introduction to clinical investigations of medical devices
- Clinical investigations which require an application
- Clinical investigations which require a notification
- Other clinical investigations
- Safety reporting in clinical investigations
- Substantial modifications to a clinical investigation
- End or temporary halt of a clinical investigation
- Clinical investigations started prior to 26th May 2021