Devices for special purposes

Medical devices for clinical investigations and in vitro diagnostic medical devices for performance studies

Researchers shall have access to devices in connection with clinical investigations, as long as these meet certain criteria set out in Articles 62 to 80 and Article 82.

Custom-made devices

Custom-made devices shall be accompanied by the statement referred to in Section 1 of Annex XIII, which shall be made available to the particular patient or user identified by name, an acronym or a numerical code. The Norwegian Medical Products Agency may require manufacturers of custom-made devices to present a list of such devices. More information regarding custom-made devices could be found at this page​.

Devices for presentation at trade fairs, exhibitions and similar events

Devices that do not comply with the regulations may be presented at trade fairs, exhibitions and similar events as long as a visible sign clearly indicates that the device is only intended for presentation or demonstration purposes and can neither be marketed nor used until it meets the requirements of the regulations. Devices for presentation and demonstration cannot be used on humans.