The new EU IVD Regulations (EU 2017/746) bring a significant impact on all IVD manufacturers with a new risk-based classification and a greater emphasis on patient safety.

About 80% of all devices will now require some form of conformity assessment by a Notified Body, impacting every part of your organization and all its economic operators.

Watch this on-demand webinar which discusses how early planning and a holistic organizational approach to implementing the changes will help you be ready in time. Additionally, we cover the following:

• Practical lessons learned from implementing the new EU Medical Device regulations (MDR)
• The importance of aligning your Quality System
• Clinical evidence requirements and aligning new post-market surveillance activities with existing processes.

During this interactive and engaging presentation, we explore the key changes that will impact your organization and how you can start prioritizing and planning your implementation strategy.