The Norwegian Medicines Agency can, according to MDR article 59 section 1, cf. act of 7 May 2020 no. 37 on medical devices § 1 first paragraph, 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:
By way of derogation from Article 52, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health.
Regarding IVD medical devices, the exemption from the conformity assessment procedure is stated in the temporary Regulation of 15 December 2005 no. 1690 on medical devices § 2-3.
The exemption rule is interpreted strictly, and an exemption must be justified in the interest of public health or patient safety. NOMA will take into consideration:
- The need for the medical device, including whether there are any alternative devices available on the market
- Justification based on a specific need of one particular patient or targeted group
- Whether the user of the medical device is a professional or lay person
NOMA does not grant an exemption on a general basis, or for an unlimited period of time
Manufacturers may submit an application by using the form exemption from the conformity assessment procedure. This form must be completed and submitted to NOMA 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.