Skip to content Norwegian Medical Products Agency Norwegian Medical Products Agency

Studies involving companion diagnostics (CDx)

Published:

|

Updated:

Changes

  • : Updated section on how to submit a notification with information about cover letter.

Page contents

    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 Medical Products Agency by e-mail to kki@noma.no​. The subject heading should include “Notification of CDx performance study using left-over samples” and the name of the sponsor and the device. The documentation to be submitted with the notification is listed below:

    Notification form

    The notification form (‘Application-Notification form’)​ must be ​completed and signed. Appendixes for part 3, 4 and 5 of the notification form ​​​​​is used if necessary.​

    Cover letter

    The cover letter should provide a description of the performance study and information on the development phase. If the study is a combined study, information should be given on the relation of the performance study to the clinical trial of the medicinal product. Please provide information on whether the application for the clinical trial of the medicinal product has already been submitted. 

    A separate application must be submitted to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) ​using the REK-portal.​ For more information, see REK KULMUs 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 REK KULMU has not issued a negative opinion.​​​

    Contact us

    Unit for medical devices - development and notified body

    (+47) 22 89 77 00

    Questions regarding clinical trials, classification and innovation guidance

    kki@noma.no