Hungarian Clinical Trial Management Society: lecture of Clinical Director on clinical trials with Medical Devices as per MDR


Pharmahungary Group Clinical Director emphasized the importance of the new European Union legislation on clinical trials during her lecture on clinical trials with Medical Devices especially clinical data and clinical investigations as per the EU Medical Device Regulation (MDR) at the yearly Good Clinical Practice (GCP) course between September 23-24, 2021. The lecture provided essential information not only for Clinical Research Organization representatives and clinical monitors but to Investigators and manufacturers as well. The most essential message of MDR in force since May 26, 2021 is the safety and clinical benefit of the medical device used in healthcare systems. Therefore, MDR has stricter requirements regarding planning, conducting, and evaluation of clinical investigations as compared to the Medical Device Directive (MDD).