1. Early termination or temporary halt of a clinical investigation

​​​​​NoMA must be notified if a clinical investigation is terminated early or in the event of a temporary halt. The notification must include a justification for the early termination or temporary halt.  

The sponsor must notify NoMA 

  • ​no later than 15 days if the clinical investigation is terminated early or temporarily halted. 
  • no later than 24 hours if the clinical investigation is terminated or temporarily halted on safety grounds. 

The sponsor must submit a clinical investigation report and a summary to NoMA no later than 3 months after termination. This also applies in the event of a temporary halt unless the investigation is recommenced within the 3 months. In this case, the report should be sent to NoMA when the clinical investigation is completed. The report must contain information about the temporary halt. 

The clinical investigation report must meet the requirements set out in MDR section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV. 

The summary accompanying the clinical investigation report shall be presented in terms that are easily understandable to the intended user. This may be health professionals and/or patients. The summary will be published. ​

2. Ordinary termination of a clinical investigation

At the end of a clinical investigation, the sponsor shall notify NoMA 

  • ​no later than 15 days after termination in Norway. 
  • no later than 15 days after termination in an EU/EEA member state (if the investigation is conducted in several member states). ​

​If the clinical investigation is conducted outside of the EU/EEA in addition to Norway, the sponsor is encouraged to notify NoMA when the investigation is ended globally. 

The sponsor must submit a clinical investigation report and a summary to NoMA no later than 1 year after termination. 

The clinical investigation report must meet the requirements set out in MDR Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV. 

The summary accompanying the clinical investigation report shall be presented in terms that are easily understandable to the intended user. This may be health professionals and/or patients. The summary may be published by the EU Commission/NoMA. 

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Publisert: 05.04.2022

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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.
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 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.
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.
Safety reporting in clinical investigations of medical deviceshttps://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-devicesSafety 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.
Substantial modifications to clinical investigationshttps://legemiddelverket.no/english/medical-devices/how-to-place-a-medical-device-on-the-market/clinical-investigation-of-a-medical-device/substantial-modifications-to-clinical-investigationsSubstantial modifications to clinical investigationsThe 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.3557Substantial 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-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.

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