GS1 Healthcare

GS1 has been designated today by the European Commission as issuing entity for Unique Device Identifiers (UDIs)

GS1 Healthcare is a neutral and open community bringing together all healthcare stakeholders to lead the successful development and implementation of global GS1 standards, enhancing patient safety, and operational and supply chain efficiencies.

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.

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.

Find the announcement on page 73 in the official Journal of the European Union