Is UDI (Unique Device Identifier) symbol mandatory under EU MDR?

Elsmar Forum Sponsor
#3
MDR covers UDI system will facilitate traceability of medical devices and significantly enhance the effectiveness of post market surveillance safety related activities. UDI system is not yet applicable for custom made devices and /or investigational devices. Manufacturer is responsible for complying with all UDI related requirements.
FDA- UDI is a requirement for device labelers ( manufacturers). If device is intended is more than one use, manufacturer is responsible to mark UDI on the device.
 

L_O_B

Involved In Discussions
#7
As far as I know, ISO 15223 included the UDI symbol last year, so that symbol is needed.
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.
 

Fjalar

Registered
#8
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?
 

StepPCHen

Starting to get Involved
#9
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?
Shall is an absolute and must be done
 

cool1984

Starting to get Involved
#10
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.
L_O_B's explanation is correct. I thought it would be difficult to justify the reason why I didn't use it even though it was specified in ISO15223-1. Therefore, I thought this "may" was the same as "shall", but it seems that my original perception was incorrect.


On the other hand, I find Fjalar & StepPCHen's opinion interesting.

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?
ISO 20417: 2021 has not yet been designated as a harmonized standard for EU MDR, but it may be necessary to think about the state of arts.
At least, if you have multiple carriers in your medical device, it seems better to use this UDI symbol...
 
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