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

January 11, 2013

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.

In the device industry, success means staying abreast of regulatory changes from Argentina to Zimbabwe. With a subscription to the International Medical Device Regulatory Monitor, you will have the resource needed to keep you knowledgeable on a global scale. Subscribe today!