| Introduction to clinical investigation of a medical device | https://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-device | Introduction to clinical investigation of a medical device | | 3470 | The 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 NoMA | https://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-noma | Clinical investigations which require an application to NoMA | Information 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. | 3474 | Information 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 NoMA | https://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-noma | Clinical investigations which require a notification to NoMA | | 3475 | Information regarding investigations of CE-marked medical devices that require a notification. |
| Clinical investigations which do not require an application or a notification to NoMA | https://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-noma | Clinical investigations which do not require an application or a notification to NoMA | Not 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. | 3483 | Information 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 devices | https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/safety-reporting-in-clinical-investigations-of-medical-devices | Safety reporting in clinical investigations of medical devices | Serious adverse events that occur during a clinical investigation must be reported to NoMA. | 3484 | Serious adverse events that occur during a clinical investigation must be reported to NoMA. |
| Substantial modifications to clinical investigations | https://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/substantial-modifications-to-clinical-investigations | Substantial modifications to clinical investigations | The sponsor must notify of planned substantial modifications to clinical investigations. The Norwegian Medicines Agency (NoMA) and the ethics committee (REK) must assess the notified changes before they can be implemented. | 3557 | Substantial modifications to clinical investigations must be notified to the Norwegian Medicines Agency and the ethics committee. |
| 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-mdr | Transitioning 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. | 3485 | 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. |
| End or temporary halt of a clinical investigation | https://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-investigation | End or temporary halt of a clinical investigation | Sponsors’ 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. | 3486 | The 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. |
