UDI (Unique Device Identification)
The UDI (Unique Device Identification) is a globally harmonised system for uniquely identifying medical devices. It consists of a UDI-DI (Device Identifier) that identifies the product and manufacturer, and a UDI-PI (Production Identifier) that encodes production-related data such as batch number or expiry date. The UDI system is a key component of the EU MDR and is managed through the EUDAMED database.
When translating IFUs, the UDI must be treated as a non-translatable identifier. Accidental modification of the UDI during the translation process can have serious regulatory consequences.
Frequently Asked Questions
Does the UDI need to be included in the instructions for use?+
Yes, according to EU MDR Annex I Chapter III Section 23.2, the UDI-DI (Device Identifier) must be stated on the label and in the instructions for use. For translated IFUs, it is essential to ensure that the UDI is correctly and consistently reproduced in all language versions.