IVDR Class C Devices: Why Early Notified Body Engagement in 2026 is Critical The 2026 deadline for the European Union’s In Vitro Diagnostic Regulation (IVDR) is no longer a distant milestone. The shift from the IVDD (In Vitro Diagnostic Directive) to the IVDR represents an increase in scrutiny, evidence expectations and post-market accountability. Where once a small subset of legacy devices…
Ben KempMay 12, 2026