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 enter into force in May 2020. The GS1 global system of standards is the most widely implemented in the world and is used by all stakeholders in healthcare supply chains.
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.
By using GS1 global standards, Healthcare manufacturers in Europe and around the world are enabled to create and maintain compliant UDIs.
About GS1 Healthcare
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.
The development and implementation of GS1 standards is led by the experts who use them: pharmaceutical and medical device manufacturers, wholesalers, distributors, group purchasing organisations, hospitals, pharmacies, logistics providers, solution providers, governmental and regulatory bodies, and trade associations. Evidence available from industry implementations shows that GS1 identification, data capture and data sharing standards in healthcare deliver tangible benefit to all stakeholders. GS1 Healthcare members include more than 100 leading healthcare organisations worldwide.