UDI barcode quality

Malomsoki Gabor

Starting to get Involved
Dears, do you know if there any guidance document which is mentioning the verification of the barcode on the UDI label? GS1 implementation guidance is referring to ISO/ IEC 15415 also IMDRF Principles of Labelling for Medical Devices is referencing to this standard. Is it an obligation to apply ISO/ IEC 15415 or we can find other way to verify the barcode on the label?
 

Philip B

Quite Involved in Discussions
Dears, do you know if there any guidance document which is mentioning the verification of the barcode on the UDI label? GS1 implementation guidance is referring to ISO/ IEC 15415 also IMDRF Principles of Labelling for Medical Devices is referencing to this standard. Is it an obligation to apply ISO/ IEC 15415 or we can find other way to verify the barcode on the label?
GS1 UK will verify three barcodes for around £60. They send you a report on readability etc. HTH
 
Top Bottom