GS1 has been designated as issuing entity for Unique Device Identification (UDI) by the European Commission
For immediate release 11 June 2019 – GS1, the leading global supply chain standards organization, 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.
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.
“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 GS1 identifiers are fundamental to enable an efficient and effective identification of medical devices from product conception through every step of the supply chain lifecycle. Strengthening patient safety is central to GS1’s mission in healthcare and GS1 is committed to support the EU Commission, manufacturers and other stakeholders worldwide in implementing the new EU UDI system.” said Miguel Lopera, President and CEO of GS1, which has headquarters in Brussels, Belgium.
Maria Palazzolo, Executive Director and CEO of GS1 Australia said, “At GS1 Australia we are pleased to see this patient safety initiative from the EU. We are delighted to be able to continue to support local medical device manufacturers in meeting global requirements.”
Since 2013, GS1 is accredited as UDI issuing agency in the U.S.A. and other regulators are also planning to allow the use of GS1 standards as the basis of their national UDI system.
According to EU Regulations, the UDI number is applied to the medical device label, its packaging, and/or the device itself. Required product data must be submitted to EUDAMED (European Database on Medical Devices). In addition, a new identifier was introduced by the EU Regulations: the Basic UDI-DI. GS1 has developed a new key (i.e. Global Model Number-GMN) to support the implementation of this requirement. By using GS1 global standards, Healthcare manufacturers in Europe and around the world are enabled to create and maintain compliant UDIs.
For more information, visit the GS1 UDI resource web page or email the GS1 Australia Healthcare team.
About GS1 Australia
GS1 Australia is the Australian member of GS1, a not-for-profit global organisation that develops and maintains the most widely-used supply chain standards in the world and a leader in facilitating efficient international business. GS1 Australia currently serves 22 industry sectors and supports more than 19,000 members nationally to improve supply chain efficiency and cost effectiveness by adopting best practice GS1 global standards. For more information visit www.gs1au.org or follow us on LinkedIn and Twitter
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