IVDR
In Vitro Diagnostic Regulation: The European Union regulatory framework governing the safety and performance of in vitro diagnostic medical devices.
The In Vitro Diagnostic Regulation (EU 2017/746) replaced the legacy In Vitro Diagnostic Directive (IVDD 98/79/EC). It drastically increased regulatory oversight across the EU, reclassifying diagnostics into a risk-based structure (Class A through D) and requiring the vast majority of IVDs to undergo independent evaluation by a Notified Body. Manufacturers must supply rigorous analytical and clinical performance evidence, maintain continuous post-market surveillance, and register records in EUDAMED.