Actualités sur les essais cliniques de dispositifs médicaux


Clinical investigations: Revision 1 of MDCG 2020-10

During category C clinical investigations (pre-market clinical investigations) sponsors have to report certain serious adverse events and device deficiencies with Excel tables. The European guidance and the form for tabular summary reporting have been updated. MDCG 2020-10/1 rev. 1 (updated guidance) and MDCG 2020-10/2 rev. 1 (updated Excel form for summary reports) should be implemented also for reports in Switzerland. Additional information concerning reporting duties are available in the Swissmedic information sheet BW600_00_015e_MB.