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UDI Compliance in EU MDR/IVDR by srdjan.djordjevic0603 is a document available to read on EtoBox.

What is UDI Compliance in EU MDR/IVDR about?

The document provides background on changes to medical device identification regulations in the US and EU. Specifically, it discusses the introduction of Unique Device Identification (UDI) system requirements in the new EU Medical Device Regulation (MDR) and In Vitro Medical Device Regulation (IVDR). While drawing from international guidance, the EU regulations include some differences in implementation. Organizations should read the guidance, understand new UDI requirements, and develop a program to ensure

Author

srdjan.djordjevic0603

Language

EN