UDI

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.

US FDA Publishes UDI Final Rule

US FDA Final Rule

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 Unique Device Identification (UDI)

Preparing for UDI

GS1 Standards for item identification, barcoding and RFID supports medical device manufacturers and labelers to efficiently meet UDI requirements.

GS1 Standards for Unique Device Identification (UDI)

EU Commission on UDI

The IMDRF is working towards harmonisation of medical device regulation. The current IMDRF chair is Laurent Selles from the EU Commission.

GS1 UDI Training

UDI Training & Advice

Would you benefit from some on-site assistance with implementing GS1 Standards and GTINs in preparation for UDI compliance?