Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).

Ther Innov Regul Sci · 2022 · PMC8294224 · PMID 34291407

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highly significantno p-value reported

The medical relevance of LDTs is highly significant though, because LDTs are used for patient diagnosis and monitoring in a wide scope of rare and/or emerging diseases in almost all fields of medical laboratory testing [ 1 ].

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