EU IVDR
Regulation
European Union
· 2017
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.
Sectoral regime. It binds the industries below; companies outside them
generally fall outside it.
Countries
Where this binds. Each links to the providers apis.io has catalogued there.
Industries
Each links to that industry as a scored cohort — so the question "how ready is this sector for the regime that governs it?" becomes one you can actually look at.