What is EUDAMED and Basic UDI-DI?

UDI stands for Unique Device Identification. The labels of medical devices contain a UDI that can be found and read by both people and machines. The UDI contains both numbers and letters in a prescribed sequence. This includes the Device Identifier identifying the product and company, and the Production Identifier. The unique device identification system ensures common standards for medical devices globally. Both the Food and Drug Administration (FDA) in the United States, and the European Union (EU EUDAMED) have established requirements for the UDI systems they have created. MedTech Dive 17 May 2021

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