Hi,
We are currently adding UDI information across our products and are unsure what we should do.
We manufacture a reusable surgical devices that has an element that is removable and can be autoclaved. The removable element has its own SKU.
We are unclear as to whether or not we are required to serialise the UDI-PI that is permanently marked on the device, we can see benefits to doing so but it will be a major headache logistically (with significant cost implications as well) given the numbers requiring marking and creating unique artwork for the marking sub contractors (I think all stakeholders agree that when we bring the process in house there are tangible benefits to the customer and us to serialising the devices) currently we engrave a human readable code but we are getting feedback from our distributors that they would prefer a machine readable 2D barcode.
So put simply, are we able to stop serialising them temporarily until we bring the process in house?
We are currently adding UDI information across our products and are unsure what we should do.
We manufacture a reusable surgical devices that has an element that is removable and can be autoclaved. The removable element has its own SKU.
We are unclear as to whether or not we are required to serialise the UDI-PI that is permanently marked on the device, we can see benefits to doing so but it will be a major headache logistically (with significant cost implications as well) given the numbers requiring marking and creating unique artwork for the marking sub contractors (I think all stakeholders agree that when we bring the process in house there are tangible benefits to the customer and us to serialising the devices) currently we engrave a human readable code but we are getting feedback from our distributors that they would prefer a machine readable 2D barcode.
So put simply, are we able to stop serialising them temporarily until we bring the process in house?