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EU Regulation Recap: Traceability and UDI, Registration, Eudamed, And More From MDR/IVDR Chapter III

 
• By Amanda Maxwell

The third chapters of the Medical Devices Regulation and IVD Regulation are substantially similar in addressing UDI, and also in dealing with subjects surrounding device identification and traceability; registration of devices and of economic operators; summary of safety and clinical performance; and the European databank on medical devices (Eudamed). This is the latest in our series of articles delving into the MDR and IVDR, chapter-by-chapter.

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Unique Device Identification (UDI) requirements are going to be among the most challenging and costly aspects of implementing the EU’s future Medical Devices Regulation (MDR) and IVD Regulation (IVDR). But what exactly will manufacturers have to do, who else will be involved, and how will the system operate? And will all economic operators have to register in the same way?

Answers to these questions are in the table below, which summarizes the key points within Chapter III of both the...

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