The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 introduced specific requirements for clinical evidence and performance evaluation, alongside ongoing obligations for maintaining IVDR certification. These requirements play a key role in demonstrating the safety and performance of IVD medical devices and ensuring continued regulatory compliance.

In this free webinar, Dr. Heike Möhlig-Zuttermeister and Sean O'Callaghan from BSI will share their insights into clinical evidence and performance evaluation under the IVDR, as well as the maintenance of IVDR certification. The session will explore key regulatory requirements, including the expectations for manufacturers regarding clinical evidence, performance evaluation and ongoing certification obligations. The speakers will also address relevant timelines, practical considerations and common challenges manufacturers may encounter when maintaining compliance throughout the device lifecycle.