##  [Demonstrating Performance of Diagnostic Devices for IVDR Compliance](/index%2Ephp/webinars/demonstrating-performance-of-diagnostic-devices-for-ivdr-compliance) 

<a>Medical Devices</a>



<a>Past Webinar</a>



## **Demonstrating Performance of Diagnostic Devices for IVDR Compliance**

**The webinar was successfully concluded on**

  **June 16, 2021.**

[Download Webinar](javascript:void(0))





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 Here is an archived version for your perusal.

#### What Was It All About?

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.