In-Virto Device Regulation

Ready or Not – Here comes IVDR

The European Union’s new regulation for in-vitro medical devices, 2017/746 (IVDR), takes effect in May 2022. While IVDR aims to increase patient safety and company transparency, it also creates heightened challenges for the entire supply chain (especially for in-vitro diagnostic companies and their medical safety program managers). In its most recent report, the European Commission …

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