How to implement Unique Device Identification (UDI) Webinar

The FDA has released the Unique Device Identification (UDI) Rule for medical devices and it is now a federal regulation for the U.S. healthcare supply chain. The E.U. is proposing a similar regulation for medical device marking and barcode labelling within Europe. Both regulations will imapct the medical device and life sciences industry in Ireland and manufacturers will need to prepare for compliance.

How can GS1 standards help with compliance with UDI?

GS1 standards, and specifically the GTIN (Global Trade Item Number) are already recognised across the healthcare industry as a unique identifier of medical devices, surgical products and healthcare supplies. The GS1 GTIN used for device identification, along with Production Information (PI) supports the FDA UDI regulation.

UDI Webinar Slides ImagePresented and facilitated by GS1 Ireland Healthcare experts, this webinar (online seminar) will explain:

  • the final FDA UDI regulation
  • proposed EU medical device identification requirements
  • how GS1 Standards can be used to meet UDI requirements
  • recommendations for both suppliers and providers on how to implement GS1 identification and bar code labelling within their organisation
  • the tools and resources available to help you get started.
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If you would like to speak to a GS1 Healthcare Expert directly please contact:

Siobhain Duggan, Director of Innovation and Healthcare, GS1 Ireland; or

Alan Gormley, Head of Industry Engagement, GS1 Ireland