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News: Four Entities to Govern UDI Regulations: European Commission

GS1, the Health Industry Business Communications Council (HIBCC), ICCBA and Informationsstelle für Arzneispezialitäten (IFA GmbH) are the four new entities which will act as the “issuing entities” for the Unique Device Identifiers (UDI). As per the FDA, these entities have come to terms with all the fulfilling criteria that require any entity to designate itself as UDI. The entities will govern considering the new medical device and in vitro diagnostic regulations.

The European Commission (EC) had previously released guidance which drafted the principles on the use of UDI. The entities will regulate mandatory principles affecting the UDI, w.e.f 27th June 2019 and operating with a stretch of five consecutive years. The EC also said that the Medical Device Coordination Group (MDCG) had found no objection with regards to the entities upon their fulfilling criteria.