Pursuant to Article 73 of Regulation (EU) 2017/746, or Section 64 of the Medical Device Law Implementation Act („Medizinprodukterecht-Durchführungsgesetz“, MPDG) applies:

Temporary Halt or Early Termination

If the sponsor has temporarily halted a performance study or has terminated a performance study early, it shall inform within 15 days the Member States in which that performance study has been temporarily halted or terminated early, through the electronic system referred to in Article 69, of the temporary halt or early termination.

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

End of a performance study

The end of a performance study 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 performance study plan. Please note: If there is still an application of the investigational IVD after the last subject visit, the last application of the IVD should be designated as the end of the performance study in the performance study plan

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

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

Performance Study Report

Irrespective of the outcome of the performance study, within one year of the end of the performance study or within three months of the early termination or temporary halt, the sponsor shall submit to the Member States in which a performance study was conducted a performance study report as referred to in Section 2.3.3. of Part A of Annex XIII IVDR.
The performance study 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 69 IVDR.

Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study, it shall be submitted as soon as it is available. In such case, the clinical performance study plan referred to in Section 2.3.2. of Part A of Annex XIII IVDR shall specify when the results of the performance study are going to be available, together with a justification.

Information on the required content of the final report is provided in Annex XIII Part A IVDR and the standard DIN EN ISO 20916 in its current version.

Notice

As long as the electronic system mentioned in Article 69 IVDR (Eudamed) cannot provide the corresponding functionality, the notifications and the report must be communicated to the Federal Higher Authority via the German Medical Devices Information and Database System (DMIDS).