2023
DOI: 10.1002/cpt.2928
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Biomarker‐Driven Developments in the Context of the New Regulatory Framework for Companion Diagnostics in the European Union

Abstract: The new In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) introduces important changes in the EU legal framework for companion diagnostics (CDx), including a new risk‐based classification system for in vitro diagnostic tests (IVDs), a first legal definition for CDx and enhanced involvement of notified bodies in the conformity assessment and certification process of CDx. The IVDR also establishes an important link between the assessment of a CDx and the corresponding medicinal product by requiring the notifie… Show more

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Cited by 4 publications
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