Derogation from the conformity assessment procedure
The Norwegian Medicines Agency may,grant an exemption from the conformity assessment procedure in accordance with MDR acrticle 59 or IVDR article 54
By way of derogation from Article 52 [IVDR Article 48], 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.
The exemption is under strict interpretation, and must be justified in the interest of public health or patient safety. The Norwegian Medicines Agency may take into consideration the following criteria:
The need for the medical device.
The availability of alternative devices 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
Exemptions are not granted on a general basis, nor for an unlimited period of time.
The manufacturer must submit the application. Please use the derogation form:
This form must be completed and submitted to the Norwegian Medicines Agency by e-mail (firstname.lastname@example.org) as a PDF file with relevant attachments