Date16.11.2021 | 16:00 - 16:45


Available dates:

Clinical evidence – Part 2: Performance studies

Regulation (EU) 2017/746 (IVDR) sets high requirements on clinical evidence, including the demonstration of scientific validity, analytical performance and clinical performance for all in vitro diagnostics devices. In the second part of this Keynote series, we discuss how to cover gaps on clinical data by carrying out performance studies. You get an overview of the IVDR requirements on performance studies, learn which parts of the standard ISO 20916 (2019) are applicable for interventional and non-interventional studies, and identify the essential aspects that you should observe while planning and conducting performance studies.


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