Studies involving companion diagnostics (CDx)
Performance studies involving companion diagnostics (CDx) using only left-over samples, and where the study does not involve any intervention or other risks for the subject, shall be notified to NoMA, as described in IVDR Article 58 (2). Performance studies that involve interventions or other risks for the subjects require an application to NoMA. Information on how to submit an application can be found on our website Performance studies which require an application.
How to submit a notification?
Until EUDAMED is available, the notification must be submitted to the Norwegian Medicines Agency by e-mail to firstname.lastname@example.org. The subject heading should include “Notification of CDx performance study using left-over samples” and the name of the sponsor and the device. The notification must include a completed and signed notification form (‘Application-Notification form’). Appendixes for part 3, 4 and 5 of the notification form is used if necessary.
A separate application must be submitted to the Regional Committees for Medical and Health Research Ethics (REK) using the REK-portal. For more information, see REKs website.
Forms for notification
When will I recive a decision?
The sponsor will receive a confirmation from NoMA that the notification has been received. The notification will not be further processed by NoMA, and the study may commence when the confirmation from NoMA is received. It is a prerequisite that the Regional Committees for Medical and Health Research Ethics (REK) has not issued a negative opinion.