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Clinical investigation of medical devices



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 Medicines 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