GS1 has been designated by the European Commission as issuing entity for Unique Device Identifiers (UDIs). GS1 global standards meet the EU Commission’s criteria for the issuance of UDIs, supporting the EU regulators in ensuring a successful implementation of the UDI system as defined by the EU Medical Device Regulation and In-Vitro Diagnostics Medical Devices Regulation (EU Regulations), and enabling manufacturers to comply with these requirements.
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. Next to the device identifier (Global Trade Item Number, GTIN) in the EU regulation a new identifier for UDI is introduced: the “Basic UDI-DI” (the Global Model Number, GMN), which allows to group medical devices with similar features within the EU regulatory database EUDAMED. On top of that, if applicable, a production identifier (Application Identifier, AI) can be assigned by the manufacturer.
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.
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