Substantial modifications to a performance study

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 Regional Committees for Medical and Health Research Ethics (REK). Please contact REK for details on submission.​

Implementation of a substantial modification

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

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.​