IVDR Survival Guide: Understanding The IVDR Product Classification System And Complying With The New Clinical Evidence And Performance Expectations

To improve patient protection and more effectively implement the guiding principles for in vitro diagnostic medical devices, the EU has been working to strengthen its regulations. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. Since the announcement, several dates were extended to allow for the complex transition from the old in vitro diagnostic medical devices directive (IVDD). On May 26, 2022, the new IVDR officially went into effect.

Despite the timeline adjustments, manufacturers are reportedly still struggling to understand the IVDR requirements. This guide addresses common questions concerning the IVDR product classification system and how to comply with the new clinical evidence and performance expectations.