The IVDR (In Vitro Diagnostic Medical Devices Regulation) ensures the safety, reliability, and effectiveness of in vitro diagnostic devices across the EU. It covers manufacturing, distribution, and use to protect public health and enhance patient safety. The regulation sets rigorous standards to mitigate risks, ensure accurate diagnoses and improve healthcare outcomes.
This guide outlines country-specific language requirements over clinical evidence, performance evaluation and post-market surveillance throughout the EU healthcare system.