First UDI deadline is fast approaching

The U.S. FDA Unique Identification rule requires all medical devices sold in the U.S. to be identified and marked, and product information to be stored in the FDA database. The first deadline for class III (high risk) medical devices was 24 September 2014.

The US FDA UDI Final Rule on the establishment of a Unique Device Identification System for medical devices was published in September 2013. The rule, with some exceptions requires medical devices distributed in the U.S. to carry a Unique Device Identifier (UDI).

The UDI system, comprised of:

  • the UDI code
  • application of the UDI to device labelling and packaging, and
  • a related database (Global Unique Device Identification Database or GUDID)

will provide a standardised way to identify devices across all information sources and systems, including electronic health records and devices registries.

For local implementation advice please contact Alan Gormley, GS1 Ireland on 01 2080660.


UDI Updates at the Global GS1 Healthcare Conference October 2014

Get all the latest news from former U.S. FDA Senior Advisor, Jay Crowley, on the experience and learnings so far and how to best prepare for the next requirements phase.

Participants will also have the opportunity to get the latest updates regarding the developing UDI regulation in Europe from Eucomed and hear how B. Braun, a global manufacturer of medical devices, is implementing UDI.

Two additional interactive sessions will provide opportunities to discuss further the reality of implementation of UDI and raise questions to the experts:

  • How to identify/mark products with panelists from Medtronic, BD, Aesculap and USDM
  • GDSN Implementation success stories - how to prepare and provide data for UDI databases with panelists from FSEnet+, Commport, GMDN and B.Braun

Read more about the conference.