Derogation from the conformity assessment procedure

Derogation from the conformity assessment procedure

By way of derogation from MDR article 52 [IVDR article 48], NOMA may authorise, on a duly justified request, the placing on the market or putting into service, of a specific device for which the procedures referred to in article 52 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. 

Submit an application

NOMA has launched an updated and user-friendly portal for easier and more secure handling of applications. To access the portal, you must log in with a username and password.

If you do not have an account, you can easily create one by following the registration instructions.

The manufacturer must submit the application along with the relevant documentation. If you are applying on behalf of the manufacturer, you must attach a power of attorney (PoA). Before you begin completing the application form, please ensure that you have the following documentation ready for upload as attachments:

• A Power of Attorney (PoA) from the manufacturer, if you are submitting the application on their behalf
• EU declaration of conformity (if the device has previously been CE marked)
• Certificate from notified body (if applicable)
• Summary of clinical evaluation/performance evaluation
• A copy of the labeling and the instructions for use
• A timeline for the conformity assessment procedure and relevant correspondence with the notified body
• Any decisions on exemptions from the conformity assessment procedure from other EU/EEA countries
• Any available documentation regarding the placing on the market in countries outside the EU/EEA

To submit the application, you must also include a statement from the user of the device. Please obtain this statement prior to completing the application form, and by using NOMA's template for user statements. If the device is to be used at multiple locations, a statement must be obtain from each healthcare institution where the device will be used.

Once you have submitted the application, you will recieve an email reciept containing a link to a secondaty form. In this form, you will be required to provide the information from the user of the device.

Click the link below to access the application form: