The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended to allow for the challenging nature of the transition from the old in vitro diagnostic medical devices directive (IVDD), the new IVDR officially applies as of May 26th, 2022.
Despite this long timeline, manufacturers still struggle 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.