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We are a Class I and II medical device manufacturer using GS1 as our UDI issuing agency. I have been trying to get a clear answer regarding barcode grading requirements via GS1 and FDA help desk. The GS1 General Specifications document breaks down the minimum quality grade required based on the operational environment according to ANSI/ISO. My question is, is the minimum grade quality a mandatory requirement for products being sold in the US or EU for example? Is read/decode only for barcode/data matrix sufficient? What are the implications / consequences if minimum barcode quality grading is not being followed? Thank you for your input!