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Derogation from the conformity assessment procedure

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​​​​The Norwegian Medical Products 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 Medical Products 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 Medical Products Agency by e-mail​ (meddev-no@noma.no) as a PDF fil​e with relevant attachments

Contact us

Units for medical devices

+ 47 22 89 77 00

medisinsk.utstyr@noma.no