​​​​​​​​​​​​​​​​​​​​​​​​Clinical performance studies should be prepared in accordance with good study practice as described in the standard ISO 20916:2019 In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice. 

All performance studies that entail risks for the subjects shall, in general, be applied for or notified to NoMA before the study may start. Performance studies that require an application or notification to NoMA must also be approved by REK (Regional Committees for Medical and Health Research Ethics).​​

The European medical devices database, EUDAMED, is delayed. Until EUDAMED is fully functional, all communication and submission of applications to NoMA shall be done via e-mail to kki@noma.no​​.

 

 

Performance studies that must be applied for to NOMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/performance-studies-that-must-be-applied-for-to-nomaPerformance studies that must be applied for to NOMA3572Information regarding which studies must be applied for, what the application must contain and how it must be submitted.
Performance studies which require a notification to NoMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/performance-studies-which-require-a-notification-to-nomaPerformance studies which require a notification to NoMA3575Information regarding notification of post-market performance follow-up (PMPF) studies and performance studies involving companion diagnostics (CDx) where only left-over samples are used .
Performance studies which shall not be applied for or notified to NoMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/performance-studies-which-shall-not-be-applied-for-or-notified-to-nomaPerformance studies which shall not be applied for or notified to NoMAPerformance studies that do not fall under Article 58(1) or (2) or Article 70 in the IVDR shall not be applied for or notified to NoMA. Such studies may commence without the involvement of NoMA, but still must meet the general requirements in IVDR.3576Performance studies that do not fall under Article 58(1) or (2) or Article 70 in the IVDR shall not be applied for or notified to NoMA.
Substantial modifications to a performance studyhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/substantial-modifications-to-a-performance-studySubstantial modifications to a performance studyIf a sponsor intends to introduce substantial modifications to a performance study, NoMA must be notified in advance.3578If a sponsor intends to introduce substantial modifications to a performance study, NoMA must be notified in advance.
Safety reporting in performance studieshttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/safety-reporting-in-performance-studiesSafety reporting in performance studiesThe clinical performance study plan shall describe in detail how the safety of the subjects is to be monitored, and how adverse events are to be registered and reported. Safety reporting shall follow the requirements of Article 76 of IVDR. ​​​​​3577Information regarding what sponsor shall report and how.
End or temporary halt of a performance studyhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/performance-studies-of-in-vitro-diagnostic-medical-devices/end-or-temporary-halt-of-a-performance-studyEnd or temporary halt of a performance studyThe sponsor’s obligations at the end of a performance study, or in the event of a temporary halt or early termination, are outlined in Article 73 of the IVDR. The requirements apply to studies subject to an application or a notification.3580Information regarding deadlines and what to report.

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