LGC BIOSEARCH Webinars

 

Getting ready for IVDR

Abstract

While the pandemic has changed and continues to change operations in many molecular diagnostics manufacturers and clinical laboratories, the time is fast approaching when these manufacturers and laboratories will also need to comply with the In Vitro Diagnostic Regulation (IVDR). An early start is advised given the expected pressure on notified bodies leading up to May 2022. However, for many, IVDR raises more questions than answers. Do you know what you need to do to get ready for IVDR?

The second in a series of webinars to help you prepare for IVDR, this webinar will help you draw up an action plan by bringing you a panel discussion and Q&A by three leaders in the field who will share with you their tips on ‘Getting Ready for IVDR’.

Topics covered

• How to establish your intended purpose and preparing the documentation
• Understand responsibilities as a manufacturer under various scenarios: What if you don’t make the product? How do broader marketing claims impact certification and liability?
• Understanding of Notified Body application process and key timelines

Speakers

Sue Spencer
Head of In Vitro Diagnostics & Principal Consultant, Qserve Group

Erik Vollebregt
Founding partner, Axon Lawyers

Dr. Julien Senac
Global Director – IVD Focus Team, TÜV SÜD