End or temporary halt of a clinical investigation
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Changes
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.
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Early termination or temporary halt
Notification on early termination or temporary halt
The sponsor must notify NOMA when 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 notification shall be made
- 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 early or temporarily halted on safety grounds
Until EUDAMED is available the notification must be submitted by email to kki@noma.no. The email must include the CIV-ID and title of the investigation, as well as NOMAs case reference number.
Clinical investigation report and summary
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 3 months. In that 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. The EU commission has developed guidelines on the content and structure of the summary of the clinical investigation report.
Until EUDAMED is available the clinical investigation report and summary must be submitted by email to kki@noma.no. The summary and the report will be made publicly accessible. Arrangements for publication in the absence of Eudamed will be made.
Ordinary termination of a clinical investigation
Notification on ordinary termination
At the ordinary termination 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 EU/EEA (if the investigation is conducted in several member states)
Until EUDAMED is available the notification must be submitted by email to kki@noma.no. The email must include the CIV-ID and title of the investigation, as well as NOMAs case reference number.
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 terminated globally.
Clinical investigation report and summary
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. The EU commission has developed guidelines on the content and structure of the summary of the clinical investigation report.
Until EUDAMED is available the clinical investigation report and summary must be submitted by email to kki@noma.no. The summary and the report will be made publicly accessible. Arrangements for publication in the absence of Eudamed will be made.
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