Results IVD performance studies
The following conditions apply to to the reporting of the results of IVD performance studies:
- Within a year of the end of the study, the sponsor must submit a report on the study. The requirements for the report are listed in Annex XIII of the IVDR (Section 2.3.3 of Section A);
- Within a year of the end of the study, the sponsor must submit a lay summary of results;
- Is it not feasible for scientific reasons to submit the report and the lay summary within a year of the end of the study? In that case the sponsor must have justified a different deadline in the clinical performance study plan (CPSP). The review committee will assess whether the extension of the deadline is justified.
- Has the study been suspended or ended prematurely? Then a period of three months instead of one year applies for submitting the report and the lay summary.
- Has the study been suspended and restarted within three months? Then the sponsor does not have to submit a report and a lay summary.
As soon as Eudamed is operational, you need to upload the results of the study in Eudamed and the report and the lay summary will be made public through Eudamed (IVDR article 73(7)).
As long as Eudamed is not operational as yet, you have to submit the report and the lay summary directly to the review committee and to CCMO as competent authority at firstname.lastname@example.org.