Welcome to GS1 Ireland The Global Language of Business
Welcome to the GS1 Ireland UDI Information Portal.Here you can find out about identifying surgical and medical devices using GS1 barcode and labelling standards to comply with U.S. FDA & EU requirements for unique device identification.
In September 2013 the U.S. FDA published its final rule requiring medical devices distributed in the US to carry a UDI or unique identifier.
GS1 Standards for item identification, barcoding and RFID supports medical device manufacturers and labelers to efficiently meet UDI requirements.
The IMDRF is working towards harmonisation of medical device regulation. The current IMDRF chair is Laurent Selles from the EU Commission.
Would you benefit from some on-site assistance with implementing GS1 Standards and GTINs in preparation for UDI compliance?