Navigating IVDR challenges for pharmacokinetic, anti-drug antibodies, and biomarker assays in early clinical research: a recommendation from the European Bioanalysis Forum.

Abstract

The European Bioanalysis Forum has observed increasing misclassification of pharmacokinetic, anti-drug antibody, and biomarker research assays not used for patient management under the European Union's In Vitro Diagnostic Regulation, despite their non-diagnostic intent in early clinical development. This misinterpretation, fueled by ambiguous protocol language, limited cross-functional awareness, and inconsistent national implementation, is leading to unnecessary delays in clinical trials and increased and non-added value regulatory burden. Through a structured evaluation involving a focus workshop and regional roadshows, the European Bioanalysis Forum identified some manageable origins of the issue and its operational consequences. This recommendation paper outlines these observations and wants to propose a pragmatic path forward. This includes clearer regulatory guidance to exempt noncommercial, non-diagnostic assays from In Vitro Diagnostic Regulation when not developed or intended as registered diagnostics. We also highlight the importance of stakeholder education and coordinated regulatory dialogue. These steps aim to preserve the regulator's intent of patient protection while enabling timely and efficient clinical research.