The implementation of the new In Vitro Diagnostic Regulation (IVDR) within the European Union (EU) has introduced profound changes with far-reaching impacts on both manufacturers and users of in vitro diagnostic devices.
Manufacturers operating within the EU are facing a vastly different regulatory landscape with the advent of the IVDR. This regulation places more stringent demands on manufacturers, necessitating a comprehensive overhaul of their operations. A primary focus is on compliance, with manufacturers required to meet rigorous regulatory requirements. This includes the submission of robust clinical data, exhaustive performance evaluations and the implementation of rigorous quality management systems.
The IVDR also introduces changes in the classification and risk assessment of in vitro diagnostic devices. Manufacturers must meticulously assess the risk profile of their products, which may lead to reclassification and the need to modify device labeling and documentation accordingly. These demands have increased the compliance burden, demanding a significant investment of time and resources.
In this webinar, our experts dive deeper into the world of IVDR and shine a light on all you need to know to be prepared
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