Module 16 2022

05/09/2022

Unique Device Identification (UDI) – What is it?

• The relevant UDI-DI and PI will be printed on the product packaging at all secondary packaging levels: • Human readable format • Machine readable format – barcode • This enables electronic scanning of the product at various points within the supply chain (if scanning is not possible then the information can be keyed in)

The Organisation for Professionals in Regulatory Affairs

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Unique Device Identification (UDI) – What is it?

• The second part of the UDI System is a series of databases where various data elements related to the product are stored against the UDI-DI • When the item is scanned within the supply chain this will retrieve information from the various systems relating to the product • In Healthcare the IMDRF (International Medical Device Regulators Forum) defined a list of 25 ‘Core’ data elements in 2013. Each region will add further elements if and when required.

The Organisation for Professionals in Regulatory Affairs

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