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Regulatory Focus™ > News Articles > 2019 > 6 > EC Selects Four UDI Issuing Entities

EC Selects Four UDI Issuing Entities

Posted 11 June 2019 | By Zachary Brennan 

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.”

The designations are valid for five years from 27 June 2019, according to the EC. Guidance on the use of UDIs has been previously released by the EC.

GS1, HIBCC and ICCBA are also accredited by the US Food and Drug Administration for assigning UDIs.

The US and EU have pledged to work together to ensure alignment of electronic database specifications for UDIs and to work with the International Medical Device Regulators Forum (IMDRF), which consulted on UDIs in 2018 and developed a guidance to help regulators develop their UDI systems in a globally harmonized way. 

Commission Implementing Decision

 

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