Clinical investigation of medical devices
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Changes
Before starting a clinical investigation of a medical device, the sponsor must determine if the investigation is subject to application, notification or neither to the Norwegian Medical Products Agency (NOMA).
Below you will find information regarding the process, NOMAs application processing, including amendments, safety reporting and termination of the investigation.
- Introduction to clinical investigation of a medical device
- 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