BASG - Austrian Federal Office for Safety in Health Care, AGES - Austrian Agency for Health and Food Safety, Austria Mr Nebojsa Serafimovic is assessor for clinical investigations with medical devices and performance evaluations with in vitro diagnostics at the AGES/BASG. Besides approving studies he is involved in the development of national processes to tackle MDR and IVDR requirements. Prior to his work at the Competent Authority, Nebo worked for Philips Austria in the field of medical device engineering and the Medical Response Center. He studied Biomedical Engineering at Graz University of Technology and at the TGM in Vienna. Nebo is member of the Clinical Investigation and Evaluation Working Group and contributes in a number of taskforces.