Hello !
We are a medical device company (surgical instruments) trying to apply MDD and FDA standards.
Currently, we put DI portion of UDI in Data Matrix on stamped our products. But, we write the lot number numericaly (seperately, not in Data Matrix).
We can provide traceability with this system.
Do we need to change our system and put one DatA Matrix as in UDI form ? If we do , which document, standard or regulation oblige us to do so ? Because in that case, i have to show my boss that it is mandotory to study another barcode system,
We are a medical device company (surgical instruments) trying to apply MDD and FDA standards.
Currently, we put DI portion of UDI in Data Matrix on stamped our products. But, we write the lot number numericaly (seperately, not in Data Matrix).
We can provide traceability with this system.
Do we need to change our system and put one DatA Matrix as in UDI form ? If we do , which document, standard or regulation oblige us to do so ? Because in that case, i have to show my boss that it is mandotory to study another barcode system,