destroyed9218
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Hi,
Is UDI symbol mandatory under EU MDR?
Is UDI symbol mandatory under EU MDR?
To the best of my knowledge, so far, the answer would be "NO, it's not mandatory yet". I guess you are referring to the ISO/DIS 15223-1 which is still in "Draft" status.Hi,
Is UDI symbol mandatory under EU MDR?
yes, you can refer to the CE compliant handler.Hi,
Is UDI symbol mandatory under EU MDR?
As far as I know, ISO 15223 included the UDI symbol last year, so that symbol is needed.
Interestingly, the ISO 20417:2021 standard (which refers to ISO 15223-1:2021) states that "
"If more than one machine readable AIDC is on the label, symbol 5.7.10 from ISO 15223-1:-shall be used to identify the UDI carrier."
So, 'shall' or 'may': which one prevails?
According to the ISO 15223-1:2021, the UDI symbol may be used when multiple data carriers are present on the label. Therefore, you can be compliant with the ISO 15223-1:2021 without using the UDI symbol. Although I would recommend just to use it, if you have sufficient space on your label.
Interestingly, the ISO 20417:2021 standard (which refers to ISO 15223-1:2021) states that "
"If more than one machine readable AIDC is on the label, symbol 5.7.10 from ISO 15223-1:-shall be used to identify the UDI carrier."
So, 'shall' or 'may': which one prevails?