MEDICAL DEVICES
IVDR Class C Devices: steps for successful transition
This year marks the start of a series of deadlines to ensure Class C medical devices remain in step with new regulations. Many diagnostic devices face a more demanding future as the new IVDR requirements are set to heighten scrutiny of laboratory and POCT equipment, as Liz Harrison explains.
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.
Under the EU’s IVDR, high impact diagnostics must withstand a level of examination that interrogates every claim, assumption and data point.
Three primary drivers define the
complexity of Class C devices: 1. Breadth of scope: diverse clinical contexts, critical intended uses and severe consequences of error.
2. Depth of evidence: analytical and clinical performance data must be comprehensive, defensible and meticulously documented, with a rigor that far exceeds lower-class
categories.
3. Regulatory rigor: the general safety and performance requirements (GSPRs) demand complete, coherent dossiers. Any gap, whether in performance evaluation data, post market performance follow-up (PMPF) planning, or risk analysis, triggers a cascade of deficiency notices that can stall certification for months.
April 2026
WWW.PATHOLOGYINPRACTICE.COM 37
AdobeStock / Vadim
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56
