Forum - is there a field for UDI codes in items registers? (FDA and EU ISO requires it)

is there a field for UDI codes in items registers? (FDA and EU ISO requires it)

Christoffer Riska

2017-09-14

The new FDA and EU ISO regulations require that Medical devices and In Vitro Diagnostic devices have UDI codes (Unique Device Identification). https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#agencies

Is there any place in the items register or support register to store UDI codes for items.

/Chris

Aldevinas Katkus

2017-09-14

I would use the item serial number number for that purpose, though in pharmacy it looks like it is not enough to have just one serial number to track the item. Starting from the 2019 there will even more requirements to track medical items ("serialization") to better fight with counterfeit goods.

Björn Schwab

2017-09-15

we added such functionality for customer. On GR you registered both serialnr and the UDI number. We then stored the UDI against the Item/serialnr in a history register. Could then be printed on documents etc.

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