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Important News for IVD and MD Manufacturers!

The European Parliament has adopted new measures, initially proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs), launch of parts of the European database on medical devices, Eudamed, and a mandatory prior notice in case disruption of supply is anti...
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Navigating medicinal products development and assessment involving companion diagnostics: A guide to addressing key questions under Regulation 2017/746 (IVDR) 

This Q&As document outlines the European Medicines Agency’s (EMA) perspective on critical issues related to the development and assessment of medicinal products, especially those involving companion diagnostics (CDx), following the implementation of Regulation 2017/746 (IVDR). It aims to o...