B19 – Beyond the CSR: Demystifying clinical evidence requirements for medical devices

An essential component of the technical file which supports an ARTG entry is the Clinical Evaluation Report.  This is more than a clinical study report.  It also must include reviews of the preclinical testing and risk assessments, relevant literature and comparisons to predicate devices.  In many cases, especially for lower risk devices, there is no direct clinical study at all.  Who creates this document and why is it required? In this session, we will discuss clinical evidence from the perspective of the Australian regulator and their requirements and from the sponsor perspective including how international requirements differ and how they can be addressed when preparing clinical evidence. Join this discussion for insight into what happens with clinical data for medical devices and why the clinical evidence report is so pivotal for the regulator.


Chairperson: Deb Cooper, Senior Manager Education, ARCS Australia