UDI size on packaging

MedicalDevice

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#1
Hi.
Does anyone know if there is a template where the acceptable (minimum-maximum) sizes of the UDI are depicted (under the MDR)?
I need to know how small we can design the UDI so it can be printed in all levels of packaging and on the IFU.

Also, does anyone know (or has experienced themselves in their organization) if there is any article or section in the MDR about the need to glue the boxes (cartons)?
Thank you in advance.
 
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rob73

looking for answers
#2
I take it by UDI size you mean the carrier i.e. barcode. For this you need to to refer to the issuing body. Most likely this will be GS1. The physical size will depend on the type of barcode , GS-128, 2d-datamatrix, EAN-13 etc.
See www.gs1uk.org or your regional version of the site, there are plenty of resources to be found there.
The MDR does not give any guidance on the gluing of cartons, that will down to your risk management, validation and verification activities on whether your packaging does what you intend it to do .i.e. protect the device.
 

MedicalDevice

Involved In Discussions
#3
Thank you rob73.
Yes, I should be more precise about what type of barcode I am interested in.
I think that 2d-datamatrix barcodes are more convenient to use, especially on primary packaging, as they do not take up as much space as the linear barcodes.
 
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