IVDR (In Vitro Diagnostic Regulation)


The IVDR (Regulation (EU) 2017/746) is the EU’s regulatory framework for in vitro diagnostic medical devices —tests performed on human samples such as blood, tissue, or urine. It sets strict rules for safety, performance, and evidence requirements, replacing the earlier IVD Directive. It covers everything from genetic tests to COVID-19 diagnostics and ensures consistency across EU member states
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