Completion of investigation

The sponsor must no later than 15 days after completion of the investigation notify the Danish Medicines Agency thereof. Upon completion of the investigation, the sponsor must, as soon as possible and no later than 12 months after, submit their final report to the Danish Medicines Agency.

The final report must include a critical assessment of all data collected during the investigation.

Notification of completion of the investigation is possible using the Danish Medicines Agency’s form for notification of completion of the clinical investigation of medical devices.

If an investigation needs to be terminated earlier than planned, or temporarily halted, the sponsor has 15 calendar days after termination to notify the Danish Medicines Agency thereof and provide a justification for the early termination or temporary halt.

The sponsor must submit the final report as soon as possible and no later than 3 months after the investigation was terminated earlier than planned. The final report must include a critical assessment of all data collected during the investigation.

Notification of completion of the investigation is possible using the Danish Medicines Agency’s form for notification of completion of the clinical investigation of medical devices.

The clinical investigation report must always be submitted to the Danish Medicines Agency no later than 12 months after the investigation ended.

Annex D of the DS/EN ISO 14155:2020 standard provides a template for  the clinical investigation report. In addition to the template provided in this standard, the minimum elements to be included in the clinical investigation report are also listed in Annex XV, Chapter III, paragraph 7. Guidance as to the content of the clinical investigation report is also provided in ”MDCG 2021-6 Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigation”.

The European Commission’s guidance on the content and structure of the summary of the clinical investigation report.

The European Commission has also published guidance on the content and structure of the summary of the clinical investigation report, which can be downloaded here.

The medical device regulation requires sponsors who have obtained authorisation to conduct a clinical investigation of a medical device in Denmark under Article 62, after 26 May 2021, to make the clinical investigation report publicly available no later than 12 months after its completion.

The sponsor must make the clinical investigation report publicly available in EUDAMED according to Article 77(7). EUDAMED is a database that is presently being prepared by the European Commission, however, the module intended for the clinical investigations is not ready yet. General information about EUDAMED is available here.

Until the module for clinical investigations in EUDAMED is ready, the clinical investigation reports will be made publicly available on the website of the European Commission as a temporary solution.

A dedicated folder on this website will be used for the ongoing publication of clinical investigation reports as studies are completed. This arrangement will remain in effect until EUDAMED is ready. The page for publication of reports may be accessed directly via this link.

If the direct link does not work, the clinical reports may be found via this path:  Circabc -> European Commission -> Health and Food Safety -> MDR Clinical investigation reports and their summaries.

When the Danish Medicines Agency, after the completion of an investigation, receives the clinical investigation report and summary, it will forward them to the European Commission. The European Commission then ensures the report and summary are made publicly available 12 months later, cf. Article 77(7) of the MDR. The publication process is described in “MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED”, which may be downloaded here.