Pursuant to Article 77 of Regulation (EU) 2017/745, or § 64 of the Medizinprodukterecht-Durchführungsgesetz (MPDG), the following applies:

Temporary Halt or Early Termination

If the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, it shall inform within 15 days the Member State in which that clinical investigation has been temporarily halted or terminated early, through the electronic system referred to in Article 73, of the temporary halt or early termination, providing a justification.

In the event that the sponsor has temporarily halted or terminated early the clinical investigation on safety grounds, it shall inform all Member States in which that clinical investigation is being conducted thereof within 24 hours.

End of a clinical investigation

The end of a clinical investigation shall be deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.

The sponsor shall notify each Member State in which a clinical investigation was being conducted of the end of that clinical investigation in that Member State. That notification shall be made within 15 days of the end of the clinical investigation in relation to that Member State.

If an investigation is conducted in more than one Member State, the sponsor shall notify all Member States in which that clinical investigation was conducted of the end of the clinical investigation in all Member States. That notification shall be made within 15 days of that end of the clinical investigation.

Clinical Investigation Report

Irrespective of the outcome of the clinical investigation, within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a clinical investigation was conducted a clinical investigation report as referred to in Section 2.8 of Chapter I and Section 7 of Chapter III of Annex XV MDR.

The clinical investigation report shall be accompanied by a summary presented in terms that are easily understandable to the intended user. Both the report and summary shall be submitted by the sponsor by means of the electronic system referred to in Article 73 MDR.

Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it shall be submitted as soon as it is available. In such case, the clinical investigation plan referred to in Section 3 of Chapter II of Annex XV MDR shall specify when the results of the clinical investigation are going to be available, together with a justification.

Information on the required content of the final report is provided in Annex XV Chapter III No. 7 MDR as well as the standard DIN EN ISO 14155 in its current version.

Notice

As long as the electronic system mentioned in Article 73 MDR (Eudamed) cannot provide the corresponding functionality, the notifications and the report are to be communicated to the higher federal authority via the German Medical Devices Information and Database System (DMIDS).