IMDRF Hoping UDI Rollout in U.S. Will Offer Roadmap for Global System

Efforts to develop a roadmap for an international unique device identifier system will draw heavily on the U.S. Food and Drug Administration’s (FDA) emerging UDI system, members of a group working on the blueprint say.

“The whole point of this work item is to design a global unique UDI system that could be the basis for full international harmonization,” Laurent Selles, deputy head of the medical devices unit of the European Commission’s Directorate-General Health and Consumers, told IMDRM.

Selles was part of an 18-member International Medical Device Regulators Forum (IMDRF) working group that met in Washington, D.C., in early December to discuss the roadmap.

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