FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

U.S. and EU Agree to Work Together on UDI Standards

Feb. 21, 2019
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The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission.

The two jurisdictions will develop a plan for a bilateral test of compatibility of respective UDI databases to go with ongoing efforts within the International Medical Device Regulators Forum, according to the commission’s Executive Working Group.

Regulatory issues have taken center stage in the work of the EWG — formed in July when President Trump and EU President Jean-Claude Juncker agreed to resolve trade issues — and a “meaningful set of short- and medium-term deliverables” were highlighted in an interim report released late last month.

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