Demonstrating Performance of Diagnostic Devices for IVDR Compliance
Thank you for your interest in Freyr’s Webinar Series (FWS). The webinar on Demonstrating Performance of Diagnostic Devices for IVDR Compliance was successfully concluded on June 16, 2021. Here is an archived version for your perusal.
In a nutshell, our in-house Regulatory expert - Priya Ray Chaudhuri, Assistant Manager – Medical Devices elaborated the following points in the session.
Overview of IVDR, with a focus on SaMD
Classification of IVDs based on the intended purpose and risk
Overview of performance data requirements for IVDs under the EU IVDR
Scientific validity reports, clinical performance reports: How they are defined for a SaMD, details of the elements and how to establish them?
Analytical performance: Key elements for a software, both as an independent and in combination, including verification and validation studies, with examples
How the performance data requirements vary with Class of the IVD?
Post-marketing compliance requirements
Sufficient clinical data, based on the state of the art
As a continuous practice, Freyr is destined to organize more webinar sessions related to Regulatory aspects of Life Sciences. We presume that you would like to be a part of all the sessions. If yes, let us have an opportunity to inform you about our next session.