With the introduction of the In Vitro Diagnostics Regulation (IVDR 2017/746), requirements for the performance rating are increasing. We will show you how diagnostic manufacturers can prove the clinical benefit, can carry out performance-based studies and do post-market surveillance. Our network will support you with various services – let’s face it together!
The presentation outlines how teams should be set up internally, what preparations should be made now and how should the Notified Bodies be addressed? Which changes are to be expected in the near future and what do companies have to prepare for? Selected focal points are: Traceability, vigilance and the European database.