Clinical investions of medical devices
In Denmark clinical investigations of medical devices require authorisation from the Danish Medicines Agency (DMA). The investigation may be initiated when the DMA has granted authorisation and the Scientific Ethical Committee has approved the investigation.
The regulatory requirements for application for authorisation for the conduct of clinical investigation pertain to the clinical investigation of non CE-marked devices and CE-marked devices, if the objective of the investigation is application of the device for an intended use for which the device is not CE-marked for.
Clinical investigations notified to the Scientific Ethical Committee prior to 1 January 2006 do not require authorisation from the Danish Medicines Agency.
Clinical investigation of CE-marked devices utilised for their intended purpose do not require authorisation by the Danish Medicines Agency. However, this type of investigation may require notification to the scientific ethical committee.
Relevant documents on clinical investigations of medical devices in Denmark, see:
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