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IVDR

Meaning

IVDR is the widely used acronym for the In Vitro Diagnostic Regulation, the European Union’s key piece of legislation governing the safety, quality, and performance of diagnostic tests used on human samples outside the body. This regulatory framework is paramount for all laboratory tests, kits, and software used in hormonal assessment, metabolic screening, and genetic analysis across the European Economic Area. The IVDR’s stringent requirements necessitate a fundamental re-evaluation of technical documentation and clinical evidence for diagnostic manufacturers. It serves as the legal standard for market access and post-market surveillance for all in vitro diagnostics.