We had a very interesting discussion this morning where the team was split in use of both Lot Numbers and UDI serial numbers. We will be having a new Class II medical device where each of the units (these are small units and not huge capital equipment) will have a UDI serial number. These units are contract manufactured in China.
The question is if Lot Number is required or would UDI be alone acceptable to demonstrate traceability?
The question is if Lot Number is required or would UDI be alone acceptable to demonstrate traceability?