What is a Unique Device Identifier (UDI)?

Unique Device Identifier Definition

A unique device identifier (UDI) is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market. The main goal of the UDI is to improve traceability of medical devices and facilitate monitoring by applicable authorities. A UDI will be mandatory for medical devices subject to MDR 2017/745 and IVDR 2017/746, except for custom-made and performance study/investigational devices. The UDI database is integrated with EUDAMED and managed by the European Commission.

What is Unique Device Identifier (UDI)

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