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.
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.