The In Vitro Diagnostic Regulation (IVDR) is a set of rules established by the European Union to ensure the safety and effectiveness of in vitro diagnostic medical devices. These devices are used to perform tests on samples such as blood or tissue to diagnose diseases. The IVDR aims to enhance patient safety and improve the quality of diagnostic testing across Europe. Implemented in May 2022, the IVDR replaces the previous In Vitro Diagnostic Directive (IVDD) and introduces stricter requirements for manufacturers. This includes more rigorous clinical evaluations and increased oversight by Notified Bodies, which are organizations designated to assess the conformity of these devices before they can be marketed.