The In Vitro Diagnostic Regulation (IVDR) represents a significant milestone in the regulation of diagnostic tests within the European Union. This regulation aims to ensure that diagnostic tests available in the European market are safe, effective, and reliable.
IVDR addresses previous gaps in the regulatory framework, particularly concerning self-certification and the limited oversight by notified bodies. By introducing stricter requirements for clinical evidence, performance evaluation, and post-market surveillance, IVDR aims to improve patient safety, enhance product traceability, and increase the reliability of diagnostic tests.