Unique Device Identification (UDI)

A worldwide system for unique identification of medical devices is introduced with European regulation (EU) 2017/745 on medical devices and (EU) 2017/746 on in vitro diagnostics (IVDR). It is based on the UDI (unique device identifier), a generic term for product recognition from basic UDI, UDI-DI and UDI-PI. The basic UDI is the main key for grouping those products of a manufacturer that have the same properties. The UDI-DI (UDI Device Identifier) is a product identifier that must be assigned to the product itself or its pack. The UDI-PI (UDI Production Identifier) contains product information such as batch number or expiry date.

The following contents are available:

UDI specifications

Detailed information on how to use IFA’s Coding System conform to UDI can be found in the specifications on the page with downloads

FAQ for UDI

Multiple answers to your questions about Unique Device Identification (UDI) and the use of the PPN as UDI-DI, can be found in the lower part of the FAQ

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