UDI-PI required on packaging (MDR)

FlatJF

Registered
Can anyone offer any clarity on the requirements for placing a UDI-PI on packaging levels under the MDR?
Is it possible to add the UDI-DI + UDI-PI (that may include the serial number, batch number, expiry date etc.) solely to the base package and then just the UDI-DI to each higher level of packaging?
I understand what details need to be included in the UDI-PI, but where I'm not clear is how I can produce the UDI-PI portion of the UDI for each higher level of packaging when there may be multiple devices with different serial numbers, batch numbers, expiry dates etc. within each packaging level.
I appreciate any thoughts/guidance you can offer.
 

yodon

Leader
Super Moderator
I don't believe your packaging requires the PI (maybe someone else will confirm). Shipping boxes don't require a UDI at all.
 

med_cert

Involved In Discussions
I didn't find any option to use UDI-DI without UDI-PI.
The requirement states, that each higher level of packaging need to be UDI marked. Both UDI-DI and UDI-PI are part of UDI carrier.

Manufacturing date could also be included in UDI-PI. Higher levels of packaging might be manufacturing date (the date of packaging - the packaging is part of manufacturing process)? It seems reasonable to me.

Shipping (transport) boxes do not require a UDI at all. There is a definition what transport box is - this is the level of packaging that is marked by a logistic company.
 

med_cert

Involved In Discussions
hello@med_cert did you find an answer ?
thanks
Well, nothing specifically. I still believe UDI shall consist of both: UDI-DI and UDI-PI. This is also the definition of UDI in many regulations (MDR, CFDA, FDA,...) For higher levels of packaging, date of manufacturing could be included as part of UDI-PI.
 
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