☆ 4.7 Editorial Material

How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

CLINICAL MICROBIOLOGY AND INFECTION (2021)

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

Pieter Vermeersch et al.

Summary: The new European In Vitro Diagnostic Regulation restricts the use of lab-developed tests after May 26, 2022. A study conducted in UZ Leuven found that while the majority of results were generated with CE-IVD methods, only 41.8% of laboratory tests were CE-IVD. LDTs were mainly used for special chemistry, flow cytometry, and molecular testing.

CLINICAL CHEMISTRY AND LABORATORY MEDICINE (2021)

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Editorial Material Medicine, General & Internal