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PubMed

Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures.

PMID: 41092101 · 2025

JournalClinical chemistry
Year2025
PMID41092101

Abstract

The European Union (EU) In Vitro Diagnostic Regulation (IVDR) imposes stringent obligations on laboratories using in-house in vitro diagnostic devices (IH-IVDs), yet offers limited clarity on whether discrete work flow steps may be subcontracted while maintaining compliance with Article 5(5). This Special Report identifies 3 systemic challenges that amplify regulatory uncertainty: (a) fragmented national implementation of the IVDR, (b) disparities in the application of ISO 15189-based quality sy

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