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Substantial modifications to a performance study

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Changes

If a sponsor intends to introduce substantial modifications to a performance study, NOMA must be notified in advance.

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    A modification is substantial if it is likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study.

    Submit a notification for a substantial modification

    The following documentation shall be submitted to NOMA by e-mail to kki@noma.no​:  

    • ​Notification form Substantial modification of performance study under In Vitro Medical Device Regulation (pdf).

    • Documents that are changed due to the planned modification. Changes shall be clearly identifiable. 

    • If the modification involves new principal investigators or investigation sites, the following must be submitted

      • ​CV for the principal investigator

      • Confirmation on the suitability of the investigational site(s). The confirmation should be signed by the person in charge at the investigational site.

    A separate notification must be sent to the Norwegian Ethics Committees for Clinical Trials on Medicinal Products and Medical Devices (REK KULMU) via the REK-portal. The notification must be submitted to NOMA and REK KULMU on the same day.

    Implementation of a substantial modification

    The sponsor may implement the modification at the earliest 38 days after NOMA and REK KULMU have been notified, unless NOMA notifies the sponsor of a refusal or a negative opinion has been issued by REK KULMU.

    The time period may be extended by an additional seven days if there is a need to consult experts in the assessment of the notification. In that case, the sponsor will be informed about the extended time period.​

    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