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In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).    Navigating the regulatory landscape of medical devices in the European Union demands a thorough understanding of both the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR). While these regulations share commonalities, such as risk-based classification...

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