The Norwegian Medicines Agency can, based on an adequate application, grant an exemption from the conformity assessment procedure which leads to a medical device being CE-marked if it is justified on grounds of the protection of health. The legal basis for an exemption for the assessment procedure is the Regulation of 15 December 2005 No 1690 § 2-3 last section. The Norwegian exemption rule is not used very often, and is interpreted strictly.
Manufacturers may submit an application with the following information:
• The manufacturer's name and details regarding the medical device
• Justification on grounds of the protection of health. Is safe and correct use ensured?
• Justification based on a specific need of one particular patient or targeted patient group
• Are there any alternative products available on the market?
• User / clinician confirmation of a specific need