End of clinical investigation
End of clinical investigation as planned
The sponsor must notify the Danish Medicines Agency within 15 days of the end of the clinical investigation. As soon as possible, and not more than one year after the end of the clinical investigation, the sponsor must submit a clinical investigation report to the Danish Medicines Agency. The clinical investigation report must contain a critical evaluation of all the data collected during the clinical investigation.
Notification about the end of the clinical investigation can be done using the Danish Medicines Agency’s form for notification of completion of the clinical investigation of medical devices.
End of clinical investigation earlier than planned
If the investigation needs to be terminated earlier than planned, or temporarily halted, the sponsor must inform the Danish Medicines Agency within 15 days of the termination, providing a justification for the termination or temporary halt.
As soon as possible, and within three months of the early termination of the investigation, the sponsor must submit the clinical investigation report. The clinical investigation report must contain a critical evaluation of all the data collected during the clinical investigation.
Notification about the end of the clinical investigation can be done using the Danish Medicines Agency’s form for notification of completion of the clinical investigation of medical devices.
Public access to clinical investigation report and summary
Within one year of the end of the investigation, or alternatively by the time the product is marketed in the EU/EEA, the sponsor must make the clinical investigation report and a summary publicly available in EUDAMED.
The clinical investigation report must always be submitted to the Danish Medicines Agency, but it is the responsibility of the sponsor to ensure that the clinical investigation report has been entered in EUDAMED once EUDAMED becomes operational.
A template for the clinical investigation report is included in Annex D of the DS/EN ISO 14155:2020 standard. In addition to the template provided in this annex, section 7 of Chapter III in Annex XV of the regulation sets out the elements that must at least be included in the clinical investigation report. Furthermore, guidance about the elements to be included in the clinical investigation report is provided in “MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation”.
Commission guidance on the content and structure of the summary of the clinical investigation report
In addition, the European Commission has published guidance on the content and structure of the summary of the clinical investigation report. The guidance is published here.