IVDR replaced the IVD Directive in May 2022 and reclassified most in vitro diagnostics into risk classes requiring notified-body conformity assessment. It brings diagnostic software explicitly into scope: an algorithm that produces a diagnostic result is a device, requiring clinical performance evidence, unique device identification and post-market performance follow-up. A diagnostic API served into the EU is a regulated product, not an integration.
EU IVDR
Statute European Union
