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What is the UDI-DI?

The UDI-DI is the fixed part of the Unique Device Identifier (UDI) required by the EU Medical Device Regulation (MDR). It identifies the manufacturer and model of a medical device. The variable part, the UDI-PI, holds the batch, serial number or expiry date. Together they appear on the product as a barcode. In the EU database EUDAMED, the manufacturer registers the UDI-DI under a Basic UDI-DI. Distributors store the UDI of class III implantable devices so they can find every unit in a recall.

Source: Regulation (EU) 2017/745 on medical devices (MDR)

T. LozerCompliance Strategy Specialist · entroit GmbH

· Updated

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