Summary
This white paper outlines the new In Vitro Diagnostic Medical Device Regulation (IVDR) and its implications for manufacturers operating in the European Economic Area (EEA). It details the significant changes introduced by the IVDR, which came into effect on May 26, 2022, replacing the previous In Vitro Diagnostic Medical Device Directive (IVDD). The paper describes the expanded definition of in vitro diagnostic devices, the new risk-based classification system, and the increased emphasis on post-market surveillance and clinical evidence. It emphasizes the need for manufacturers to update their quality management systems to comply with the new regulations, highlighting the potential consequences of non-compliance, including fines and market access issues. Additionally, the paper provides a timeline for the transition to IVDR compliance and outlines the roles and responsibilities of economic operators, including manufacturers, authorized representatives, importers, and distributors, in ensuring adherence to the new regulatory framework.
