Competent Authority Update on Preparing for IVDR Clinical Performance Study Applications

29 Min

Price

$80 Per person

Lecturer

Nebojsa Serafimovic

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.

Description

Performance Studies grow in their importance and quantity. The IVDR brings immense changes with it and affects IVD-regulation from their classification to the performance evaluation. This presentation is meant to provide clarification on what changes Competent Authorities need to apply in the regulatory framework and how this will affect clinical performance studies from a regulatory perspective. Upcoming application procedures, timelines and applicable legislation and guidance will be addressed. IVDs will experience a bigger change than other medical devices and therefore an elementary introduction to the clinical performance study procedures and potential interfaces to medicinal product studies will be addressed.