Regulatory, quality and clinical affairs

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IVDR - In Vitro Diagnostic medical devices Regulation EU 2017/746

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Description

This legal document covers specifically the IVD. It is the sister regulations from the MDR. We won't use it during the course, it is provided for your reference.

The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is the European Union’s regulatory framework for in vitro diagnostic (IVD) devices, ensuring high standards of safety, performance, and reliability.