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 from the conformity 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 by using the form exemption from the conformity assessment procedure. This form must be completed and submitted to the Norwegian Medicines Agency by e-mail as a PDF file. Once we have processed the application, a reply will be sent back to the manufacturer by e-mail.