Getting ready for In Vitro Diagnostic Regulation (IVDR)

While the pandemic continues to force many molecular diagnostics manufacturers and clinical laboratories to adapt their operations, the time is fast approaching when they will also need to comply with the new 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. Over the next three months, we will bring you a series of webinars to help you prepare for the transition, providing you with everything you need to know to get ready for IVDR.

In this session, we will bring you a panel discussion and Q&A with three leaders in the field to help you draw up an action plan for the transition to IVDR.

By attending this webinar, you will learn:

• How to establish your intended purpose and prepare the documentation
• Responsibilities as a manufacturer under various scenarios, including if you don’t make the product, and how broader marketing claims impact certification and liability
• The notified body application process and key timelines

Who should attend?