IVD Instruments under IVDR - Classification and IVD Instrument Testing

ABOUT THE WEBINAR

The complex EU conformity assessment process for in vitro diagnostic medical devices in combination with changes to the In Vitro Diagnostic Medical Device Regulation (IVDR) implementation timelines, can make the transition a complicated and time-consuming process for most IVD device manufacturers.

In this joint webinar, esteemed experts from TÜV SÜD and Qarad will walk participants through a general introduction of IVDR, setting the framework of the European Union (EU) legislation and classification of IVD instruments. They will also cover the point of view of the Notified Body and share relevant testing services for IVD instruments. 

Our webinar will tackle these points, focusing on:

• Instruments under the IVDR, transition timelines & conformity assessment routes

• Notified Body point of view

• TÜV SÜD’s IVD instrument testing service offerings

• Q&A session (15 mins)

SPEAKERS