Performance studies which require a notification to NoMA

​​​​​​​​​​​​​​​​​​​​Notification about a post-market performance follow-up (PMPF)-study

PMPF studies as described in the IVDR article 70.1 shall be notified to NoMA. These are performance studies where a device which already bears the CE marking will be further assessed, within the scope of its intended purpose, and where: 

• ​subjects are submitted to procedures additional to those performed under the normal conditions of use of the device
• and those additional procedures are invasive or burdensome

PMPF studies which do not involve procedures as described above do not have to be notified to NoMA. Where a performance study is to be conducted to assess a device which already bears the CE marking, outside the scope of its intended purpose, it must be evaluated whether the study should be applied for to NoMA.

​The documentation to be submitted with the PMPF notification is listed below. The requirements for the documentation are further described in Annexes XIII and XIV in the IVDR. 

• Notification form, duly filled in
• Instructions for use for the device
  
• A performance study plan, in accordance with IVDR, Annex XIII, Part A, point 2.3.2.
• Information on the investigator(s) and investigation site(s) 
• Proof of insurance cover of the subjects of the study. ​​The documentation shall confirm that any damage that may occur during the clinical investigation is covered by the insurance. It can be a copy of email correspondence with The Norwegian System of Patient Injury Compensation (NPE), or a copy of insurance certificates from an insurance company.
• Patient information document and informed consent form. Templates for the patient information document and informed consent form can be found on the Regional Committees for Medical and Health Research Ethics (REK) website​.
• Description of the protection and confidentiality of personal data. See IVDR, Annex XIV, Chapter I, point 4.5 for more information.
  

​The notification must be submitted by email to meddev-no@noma.no. The subject heading should include “IVD PMPF notification, ”.

An identical notification must be submitted to NoMA and the Regional Committees for Medical and Health Research Ethics (REK) on the same day. The notification to REK is submitted using the REK-portal.​

The sponsor will receive a confirmation from NoMA that the notification has been received. The PMPF study may commence 30 days after submission of the notification unless the sponsor is informed of otherwise.

It is a prerequisite that the Regional Committees for Medical and Health Research Ethics (REK) has not issued a negative opinion.​​