European and Global Ramifications Details of the FDA’s draft UDI regulation remain unknown,

European and Global Ramifications

Details of the FDA’s draft UDI regulation remain unknown, but how closely it hews to the GHTF guidance is a key question. If the FDA’s UDI system fits nicely within the GHTF recommendations, then that system presumably would serve as a model for the rest of the world.

UDI also magnifies the importance of the GMDN codes, and signifies its arrival as the global system to be used for medical device nomenclature.

UDI has yet to be required in Europe, but the medical device industry should anticipate its eventual introduction into the European Union. Regardless of which final iteration a global UDI system takes, medical device industry participants should expect a major impact. New labeling requirements as well as data management functions will need to be addressed, which no doubt will strain some manufacturers’ internal resources, at least in the short term following implementation.

That’s a lot to ask—especially for smaller-tier firms—but the end result of such an endeavor is too compelling to delay any longer.