IVDR Class C Devices: steps for successful transition

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 moved through the system with minimal oversight, today many high impact diagnostics must withstand a level of examination that interrogates every claim, assumption and data point.
   If the regulatory landscape were a marathon, the finish line hasn't moved - but the distance has tripled. Submission volumes have surged, technical requirements have deepened, and the required evidence has expanded significantly. What was previously
a mostly self-declared pathway has transformed into a legislative framework where notified body oversight is no longer the exception but the norm. The result? A system that demands earlier preparation, stronger evidence, and more rigorous lifecycle management.

Demands of Class C devices
Class C devices sit at the intersection of both innovation and clinical developments. They include infectious disease assays that guide isolation decisions, oncology markers that shape therapeutic pathways, and genetic tests that underpin personalised medicine. Their importance is matched only by their complexity.
   Three primary drivers define the complexity of Class C devices:

   As these strands intertwine, review timelines inevitably lengthen. With the 2026 deadlines approaching, the pressure to submit a technically robust dossier intensifies.