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GS1 designated as Issuing Entity for Unique Device Identification (UDI) by the European Commission

Medical devices


GS1 has been designated by the European Commission as issuing entity for Unique Device Identifiers (UDIs). Global GS1 Standards meet the European Commission’s criteria for the issuance of UDIs and will support the EU regulators in ensuring a successful implementation of the UDI system as defined by the EU Medical Device and In-Vitro Diagnostic Medical Devices regulations, and enabling manufacturers to comply with these requirements that will enter into force in May 2020.

The UDI system intends to provide a globally harmonised framework for identification of medical devices to enhance quality of care, patient safety and business processes.

GS1 has been accredited as UDI issuing agency by the U.S. Food and Drug Administration since 2013, and other regulators are also planning to allow the use of GS1 standards as the basis of their national UDI system.

You can access here the press release