AdvaMed Pushes for Globally Harmonized UDI System

U.S. industry group AdvaMed is working with regulators around the world to ensure a global approach to unique device identification — to avoid scenarios where different countries’ UDI systems can’t communicate with one another.

So far, the U.S. is the only country that has implemented a UDI system, although its final rule is still being phased in. The U.S. system is largely in line with the International Medical Device Regulators Forum’s guidance on UDI.

AdvaMed is encouraged by the fact that some countries are showing interest in following the IMDRF guidance, which allows for local variation as the need arises, but has a consistent foundation, says Jeff Secunda, vice president of technology and regulatory affairs. Canada said recently that it will base its UDI system on the IMDRF model.

The U.S. FDA and European Commission have been working with Chinese regulators and recently received indications that the country may be moving toward use of IMDRF’s model as well, says Kimberly Trautman, the FDA’s associate director of international affairs.

Erik Vollebregt, an attorney with Axon law firm in the Netherlands, says the EU is looking to implement UDI once the medical device regulations are finalized. It should be compatible with both the U.S. and IMDRF systems, he adds.

In the U.S., UDI is being phased in starting with the highest-risk devices last September. Starting in 2016, Class II devices must bear unique barcodes, and in 2018, Class I and unclassified devices must have UDIs.

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