UDI (Unique Device Identification)
The mandatory identification system for medical devices under the EU MDR and US FDA rules.
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UDI is the global system that makes medical devices identifiable and traceable. In the EU it is mandatory under the MDR (Medical Device Regulation), in the US under FDA rules. Every device carries a UDI code on its label, both human-readable and in a barcode or DataMatrix.
The code has two parts. The UDI-DI (Device Identifier) is the fixed part identifying the product and manufacturer; you register it in the European EUDAMED database or the American GUDID. The UDI-PI (Production Identifier) is the variable part: batch or serial number, production and expiry date. GS1 is one of the designated issuing agencies, so in practice the UDI-DI is often a GTIN.
For the labeling process, UDI means variable data per batch or serial number, an audit trail proving which label was printed when, and no room for manual entry. That is exactly the territory of the Compliance edition of Loftware Cloud.
Source: FDA — UDI System
Frequently asked questions — UDI (Unique Device Identification)
What does a UDI code consist of?
The UDI-DI (fixed part: identifies the product and manufacturer) and the UDI-PI (variable part: batch or serial number, production and expiry date).
Is UDI mandatory?
Yes. In the EU via the MDR (registered in EUDAMED) and in the US via the FDA (registered in GUDID).
Is a UDI-DI the same as a GTIN?
Often yes. GS1 is one of the accredited issuing agencies, so in practice the UDI-DI is frequently a GTIN.
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