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The new European In Vitro Diagnostic Regulation restricts the use of lab-developed tests after May 2022. Compliance for LDTs will require a major investment of time and effort. Clarification is needed on the degrees of freedom laboratories have to use LDTs to improve patient care.
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This page is a summary of: The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care, Clinical Chemistry and Laboratory Medicine (CCLM), July 2020, De Gruyter,
DOI: 10.1515/cclm-2020-0804.
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