Abstract

Where are Things with the IVDR?

Erik Vollebregt, Partner, Axon Lawyers

The EU IVDR has completely shaken up the EU regulatory environment for market access and regulation of IVDs in Europe. It has been and continues to be plagued by bottlenecks, capacity issues and lack of essential elements for implementation (such as the Eudamed database, designation of reference labs and essential guidance). It has been amended to change the transitional regime early 2022. Where are things with the IVDR at this moment? This presentation will give an overview of the state of affairs of the EU IVDR at the moment and what things are crucial for IVD companies to take into account for a successful transition to the IVDR.