Europe – EC Selects Four UDI Issuing Entities

The European Commission (EC) last week revealed that GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) will be issuing entities for unique device identifiers (UDIs).

The four companies submitted applications and were accepted by the EC to be a part of the system assigning UDIs under the EU’s new medical device and in vitro diagnostic regulations, as they satisfied the relevant criteria for designation. The EC said it also worked with the Medical Device Coordination Group (MDCG), “which did not raise any objection.”…