With the implementation of the IVDR, clinical performance studies on In Vitro Diagnostic Medical devices are becoming a central pillar of the device’s clinical evidence.
 
As soon as a device is used for a diagnosis purpose on human samples, the EU Competent Authorities are expecting clinical evidence supporting the safety and performance of the device, when used as intended. This means that for some IVD devices, data obtained through a clinical performance study is becoming a must-have for its placement on the EU market.
 
But what exactly is a clinical performance study?
Which IVD devices require collection of clinical evidence through a clinical performance study?
When is the right moment in a device’s lifecycle for conducting a clinical performance study?
How do I handle clinical data gathered through previous clinical performance study?
Is it mandatory to use the ISO 20916 standard?
 
In order to avoid delays in the marketing approval process, it is important to understand the full clinical workflow for each type of IVD device.
 
Join us for this webinar during which our expert Julianne Bobela will guide you through an IVD’s Clinical workflow, including:
 
· The type of clinical data needed
· The device-specific needs for clinical performance studies
· The characteristics of interventional clinical performance studies
· The regulatory requirements for conducting clinical performance studies
 
Ready to join us? Register now!