Clinical chemistryHumansEuropean UnionEuropePatient Safety
Regulatory Fragmentation in Europe and Its Risks for Patient Access and Safety: Subcontracting Work Flow Steps of In-House Diagnostic Procedures.
Raymond Nistor-Gallo, Kurt Zatloukal, Karin Schwenoha
Published: 202510.1093/clinchem/hvaf123
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 whil…
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