UDI placement - Packaging levels

MedicalDevice

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#1
Hi,

I am currently building a symbols table to assist myself and my colleagues in implementing upcoming artwork changes that will need to be done soon (screenshot below: )
1572261707503.png


According to this table, I am trying to show what symbols need to appear in all 3 levels of packaging and the IFU documentation.
While reading the new MDR and other MDR related articles I came along the statement that the UDI should appear (either in linear-barcode form or data matrix as shown above) in all 3 levels of packaging.

I would like to ask: Isn't this regulation very expensive to implement since we will need to have a different UDI for every different batch/lot for a tube label(primary) for example? If the UDI concerned only the DI that would be no problem. The PI (different exp.date, LOT etc every time) part of the UDI though needs to change according to every new lot, which seems rather costly to me.

Thoughts or comments on this?

Thank you in advance for your input,
Mike
 
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kunal9218

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#2
Hi Mike, UDI in itself is complicated and companies are having a hard time to implement considering the cost and the manufacturing plants are not UDI ready! Yes it is costly but needs to be done in order to comply with EU MDR.
 
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