CALL-to-ACTION: New EU Unique Device Identification system requires new identifier: Basic UDI-DI

The Industry Engagement Steering Committee (IESC) approved today to move the Basic UDI-DI work effort into Standards Development within the Global Standards Management Process (GSMP).

With recent approval by the European Parliament on 5 April 2017, new medical device regulations for both general and in-vitro diagnostic devices are helping to advance the unique device identification (UDI) system in Europe.

GS1 has been provisionally designated by the European Commission (EC) as one of the UDI-issuing entities for the EU. Yet, to be considered for final designation as an UDI-issuing entity, GS1 must meet specific selection criteria—one being the provision of a solution that implements the “Basic UDI-DI”.

What is the urgent need?

A new standard must be developed to enable the implementation of the Basic UDI-DI for medical device companies worldwide and, as a result, allow them to use GS1 standards for UDI in Europe.

Organisations who wish to participate in this GS1 Standards Development (GSMP) Working Group must sign the GS1 IP Policy and the opt-in agreement for this group.

Steps to Join
1. a) eSign the GS1 Intellectual Property Policy and
     b) eSign the Work Group Opt-In Agreement or Automatic Opt-in (for all work groups)
2. Request to join this group's Community Room: Click here

 

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