Derogation from Conformity Assessment Procedures for Medical Devices and IVDs in Norway

1. Legal Basis

By way of derogation from the normal conformity assessment procedures (MDR Article 52 or IVDR Article 48), the Norwegian Medicines Agency (NoMA) may authorise the placing on the market or putting into service of a specific device for which the procedures have not been carried out, but use of which is in the interest of public health or patient safety or health. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

2. Conditions and Criteria

The exemption is interpreted strictly. NoMA may consider:

• The need for the medical device
• Availability of alternative devices on the market
• Justification based on specific need of one particular patient or targeted group
• Whether the user is a professional or lay person Exemptions are not granted on a general basis nor for an unlimited period of time. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

3. Application Requirements

The manufacturer (or authorised representative with Power of Attorney) must submit an application via NoMA's portal. Required attachments include:

• Power of Attorney (if applicable)
• EU declaration of conformity (if previously CE marked)
• Notified body certificate (if applicable)
• Summary of clinical/performance evaluation
• Copy of labelling and instructions for use
• Timeline for conformity assessment and correspondence with notified body
• Previous exemptions from other EU/EEA countries
• Documentation of placing on the market outside EU/EEA A user statement using NoMA's template is mandatory for each healthcare institution. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

4. Submission Process

After submitting the main application, an email receipt is received with a link to a secondary form for user information. The portal requires login; new users can register. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

5. Relevant EU Regulations

• MDR - Regulation (EU) 2017/745 on medical devices (Article 59)
• IVDR - Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Article 54) https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

6. Practical Implications

Derogations are exceptional and time-limited. Approved devices must still meet essential safety and performance requirements. Manufacturers should prepare comprehensive justification and documentation to support the application. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure

7. Contact and Support

For questions, contact NoMA Medical Devices Unit at +47 22 89 77 00 or meddev-no@noma.no. The application form and user manual are available through the portal. https://www.dmp.no/en/medical-devices/development-and-manufacturing/conformity-assessment/derogation-from-the-conformity-assessment-procedure