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).

https://mavenprofserv.com/comp....arison-and-highlight

InVitroDiagnosticRegulation
MedicalDeviceRegulation
MDRandIVDRintheEU
IVDR
MDR

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