Unique Device Identification (UDI) is a method of labeling and identifying medical devices to provide a globally unique identification in both distribution and use to increase traceability.<\/p>\n\n\n\n
Many countries are adopting laws that require companies that manufacture, label or distribute medical devices<\/a> to identify them with a UDI.\nImportant information to know is that a Global Trade Item Number (GTIN)<\/a> issued by GS1 Sweden can be used as a UDI in several countries and territories such as the United States. <\/p>\n\n\n\n The US Food & Drug Administration (FDA)<\/a> and the European Commission<\/a> have developed a number of rules and regulations<\/a> to improve patient safety. The aim is a coordinated and consistent approach at global level, to increase patient safety and optimize patient care through coordinated legislation for UDI and using global standards.<\/p>\n\n\n\n The US UDI Regulation describes how devices classified as medical devices<\/em> are regulated and can be supplied in the US. It covers several classes of products sold in the United States and includes requirements related to identification, data collection, and trade item information. Legal requirements from the FDA are aimed at suppliers who use GTIN<\/a> for their medical devices classified under the UDI and sold to the US market.<\/p>\n\n\n\n GS1 is authorized as a UDI issuing agency by the FDA in the US. This means that GS1 is required by law to annually disclose which companies use GTIN to assign UDI to their products where they are sold in the United States. This information is regularly required to the US FDA.<\/p>\n\n\nRegulations of UDI<\/h2>\n\n\n\n