In Vitro Diagnostic Regulation in the European Union (EU IVDR)

Course overview

In vitro diagnostic (IVD) is a category of regulated medical devices which are used to collect, prepare, or examine human tissue for clinical use such as diagnosis of disease or determining state of health. Regulation (EU) 2017/746 is a legislative framework for IVDs that was adopted in the European Union (EU) in 2017 with the transition to its full implementation ongoing. The IVDR introduced multiple changes to the IVD sector in the EU such as a new device classification system, greater involvement of notified bodies, and designating reference laboratories to serve as central testing sites for high-risk IVDs. This session is for individuals wanting to learn about the IVDR and the ongoing transition period. It does not assume any prior knowledge about IVDs or operating in the EU. Learning about the global aspects of the life sciences industry is helpful for career growth and leadership development.