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:
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.