UDI in EU vs FDA

gwolfe2208

Starting to get Involved
I have a question. We are making a change to a name of a Class I medical device. The only change will be the name. By reading regulations and guidances, the FDA will not require a new UDI, however, the EU will. Has anyone encountered this scenario? and how was it handled? Did you revise the UDI for both and also the Basic UDI?
 
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