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

GS1 has been designated today by the European Commission as an 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. This enables manufacturers to comply with these requirements that enter into force in May 2020.

 Access the press release here

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 US FDA since 2013, and other regulators are also planning to allow the use of GS1 standards as the basis of their national UDI system.

Read the UDI in Europe brochure and the updated GMN executive summary

GS1 UDI Resource Webpage: http://www.gs1.org/healthcare/udi