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Clinical investigation of medical devices

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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.​​​​​

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