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.
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)
Marta Carnielli, Pharm D
Head of Certification IVD, TÜV SÜD
Dr Alexander Stock
Project Manager IVD Medical Device Testing, TÜV SÜD
Dr. Maurizio Suppo
Vice President, Qarad
Middle East and Africa