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Navigating the Transition: From IVDD to IVDR Compliance

Year: 2025
Type: conference-paper
Abstract: The transition from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a pivotal regulatory advancement in the EU for in vitro diagnostic (IVD) devices. Effective from 2022, the IVDR (2017/746) addresses the IVDD's limitations by introducing stringent re
Language: English
Open Access status: gold
OpenAlex ID: W4414481208
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