UDI is based on globally unique machine readable product identifiers (e.g. via barcodes), which correspond to the human readable labels and are stored in the respective databases. The goal is to improve patient safety by a better traceability, simplifying product recalls and market surveillance. Both, in the US and in the EU different issuing agencies are allowed. Nevertheless, for medical devices GS1 has become most widely accepted.

In the US UDI is already required since a few years. This includes

• labelling of the respective products and their packaging as well as
• submitting the required data to the GUDID database (Global Unique Device Identification Database).

MDR/IVDR introduces unique device identification in the EU as well. This is defined in article 27 and further detailed in Annex VI; the EU commission will setup and manage the corresponding UDI database (article 28). According to art. 123 f) manufacturers had/have to place a UDI carrier on all products and packages until:

Medical Device                         Dates

• implantable products        26 May 2021
• class III                             26 May 2021
• class IIa und IIb                26 May 2023
• class I                               26 May 2025

For the respective reusable products that have to bear the UDI carrier on the device itself two more years have been granted.