The Impact of the IVDR and MDCG 2023-1 on LDT

The Impact of the IVDR and MDCG 2023-1 on LDT

IVD NEWS January 12, 2023

On May 26, 2022 the new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has become fully applicable with major consequences not only for manufacturers of IVDs but also for all diagnostic laboratories, particularly those that manufacture in-house…

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Companion Diagnostic in Precision Medicine

IVD NEWS 27 November, 2021

65% of EMA and FDA drug approvals involved a biomarker between 2015 and 2019.  Currently, 44 CDx are approved by the FDA, and the most relevant categories in terms of the number of approvals are NSCLC and colorectal cancer.