Selected category: Class C tests

The European Union’s In Vitro Diagnostics Regulation (IVDR) replaces the In Vitro Diagnostic Medical Devices Directive (IVDD), completely overhauling the regulations regarding pre- and post- market requirements for IVD devices. This has implications for the entire supply chain, from manufacturers with responsibilities for design, development and commercialization, to agreements between manufacturers and key economic operators, such as importers and distributors. The regulation also introduces specific requirements and limitations on hospitals and labs developing their own diagnostic tests, which must review and, if necessary, replace in-house assays with commercially available CE-marked, IVDR- certified alternatives to ensure compliance for the chosen application.