Performance studies that must be applied for to NOMA | https://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-noma | Performance studies that must be applied for to NOMA | | 3572 | Information 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 NoMA | https://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-noma | Performance studies which require a notification to NoMA | | 3575 | Information 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 NoMA | https://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-noma | Performance studies which shall not be applied for or notified to NoMA | Performance 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. | 3576 | Performance 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 study | https://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-study | Substantial modifications to a performance study | If a sponsor intends to introduce substantial modifications to a performance study, NoMA must be notified in advance. | 3578 | If a sponsor intends to introduce substantial modifications to a performance study, NoMA must be notified in advance. |
Safety reporting in performance studies | https://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-studies | Safety reporting in performance studies | The 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. | 3577 | Information regarding what sponsor shall report and how. |
End or temporary halt of a performance study | https://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-study | End or temporary halt of a performance study | The 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. | 3580 | Information regarding deadlines and what to report. |