Mitteilungen über Leistungsstudien mit In-vitro-Diagnostika


Performance studies: MDCG 2024-4

During category C interventional performance studies of IVDs (pre-market studies) sponsors have to report certain serious adverse events and device deficiencies with Excel tables.

A European guidance document and a form for tabular summary reporting have been published. The new guidance (MDCG 2024-4) and the Excel form for summary reports (MDCG 2024-4 Appendix) should be used also for reports in Switzerland. Additional information concerning reporting duties are available in the Swissmedic information sheet BW600_00_016e_MB.