​​​​​Below you will find information regarding the process, NoMAs application processing, including amendments and termination of the investigation.​​​​​

 

 

Introduction to clinical investigation of a medical devicehttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/introduction-to-clinical-investigation-of-a-medical-deviceIntroduction to clinical investigation of a medical device3470The sponsor must determine if the planned investigation falls under the definition of a clinical investigation and if the device falls under the definition of a medical device under MDR.
Clinical investigations which require an application to NoMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/clinical-investigations-which-require-an-application-to-nomaClinical investigations which require an application to NoMAInformation regarding which investigations that require an application, including how to apply and when and how you will receive a decision. We recommend that the sponsor contacts NoMA if he plans to or is in the process of submitting an application. 3474Information regarding which investigations that require an application, including how to apply and when and how you will receive a decision.
Clinical investigations which require a notification to NoMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/clinical-investigations-which-require-a-notification-to-nomaClinical investigations which require a notification to NoMA3475Information regarding investigations of CE-marked medical devices that require a notification.
Clinical investigations which do not require an application or a notification to NoMAhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/clinical-investigations-which-do-not-require-an-application-or-a-notification-to-nomaClinical investigations which do not require an application or a notification to NoMANot all clinical investigations require application or notification to NoMA. Here you will find information regarding which clinical investigations fall into this category. Please note that there are still formal requirements to these investigations. 3483Information regarding clinical investigations that do not require application nor notification to NoMA. Please note that there are still formal requirements to these investigations.
Safety reporting in clinical investigations of medical deviceshttps://legemiddelverket.no/Sider/Safety-reporting-in-clinical-investigations-of-medical-devices.aspxSafety reporting in clinical investigations of medical devicesSerious adverse events that occur during a clinical investigation must be reported to NoMA. 3484Serious adverse events that occur during a clinical investigation must be reported to NoMA.
Transitioning from the old EU Directives to the new Regulation (EU) 2017/745 (MDR)https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/transitioning-from-the-old-eu-directives-to-the-new-regulation-eu-2017745-mdrTransitioning from the old EU Directives to the new Regulation (EU) 2017/745 (MDR)The new European database on medical devices (EUDAMED) is delayed. We do not know when the module for clinical investigations will be available. In the meantime, NoMA will provide alternative solutions for the process’s dependent on EUDAMED.3485The new European database on medical devices (EUDAMED) is delayed. We do not know when the module for clinical investigations will be available. In the meantime, NoMA will provide alternative solutions for the process’s dependent on EUDAMED.
End or temporary halt of a clinical investigationhttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/end-or-temporary-halt-of-a-clinical-investigationEnd or temporary halt of a clinical investigationSponsors’ obligations at the end of a clinical investigation or in the event of a temporary halt or early termination are described in MDR Article 77. The requirements apply to investigations that require application or notification to NoMA. 3486The requirements at the end of a clinical investigation or in the event of a temporary halt of a clinical investigation are described in MDR Article 77. The requirements apply to investigations that require application or notification to NoMA.

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