GS1 has been designated by the European Commission as the issuing authority for Unique Device Identifiers (UDIs). The GS1 global standards meet the Commission’s criteria for issuing UDIs, not only supporting European regulators ensure the successful implementation of the UDI system – as defined by the EU Medical Device Regulation and In-Vitro Diagnostics Medical Devices Regulation (EU Regulations) – but also enabling manufacturers to comply with these regulations.

What is UDI (in Europe)?

The Unique Device Identification (UDI) is a system used to mark and identify medical devices within the healthcare supply chain. Besides the device identifier (Global Trade Item Number GTIN), the EU regulation introduces a new identifier for UDIs: the “Basic UDI-DI” (Global Model Number, GMN), which allows grouping medical devices with similar features within the EU regulatory database EUDAMED. Moreover, if applicable, the manufacturer can assign a production identifier (Application Identifier, AI).

Benefits

The implementation of UDI can enhance patient safety and improve efficiency in the healthcare supply chain. It will enable more accurate reports of adverse events, more effective management of medical device recalls and reduction of medical errors.

Additional information

For questions, further information or assistance, please contact us or reach out to your local Member Organisation.