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In Vitro Diagnostic Regulation

Meaning

The In Vitro Diagnostic Regulation (IVDR) is the European Union’s comprehensive legal framework governing the placing on the market, availability, and use of in vitro diagnostic medical devices (IVDs) within the EU. This regulation establishes stringent requirements for quality, safety, performance, and clinical evidence for all IVDs, including tests used in endocrine assessment and personalized medicine. The IVDR aims to enhance patient safety and public health by modernizing the regulatory landscape for these critical diagnostic tools. Compliance with the IVDR is mandatory for all manufacturers seeking to market IVDs in the European Economic Area.