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
Referenced in API Evangelist papers
This regulation shows up in my published research. These reports read the machine-readable evidence provider by provider — and put this regulation in the context of a real sector.
The State of Biotechnology APIs
Named by 2 of 999 companies — the regulation that turns a diagnostic algorithm behind an API into a certified medical device, and which almost no one in this market has yet written down.
