Labeling collection device that can be used with multiple tests


We have a IVD collection device that can be used for multiple laboratory tests from a single collection event. The tests use the same sample and collection device with the only difference being the test method at the laboratory. I am looking into the rules for DI+PI for configurable medical devices and wondering if our device can qualify. For this type of device a UDI is needed plus traceability from the patient to the serial number for the configuration.

Digitally we know how each serialized collection device is configured and this configuration follows the serialized device into the lab so the lab knows which test to run. We would like to label the all collection devices during production with the same DI+PI type labels because we don't know what tests will be ordered on a collection kit at the time of production.

Our proposal would be to add a label during fulfillment that identifies the test(s) that are ordered in human readable format only and provide digital links to the required unique package insert information for each test.

For example, a sticker stating "Tests Ordered" and their catalog number + test name and also provide a QR code on this label to the test(s) package insert with performance, warnings, and limitations, etc. This way we only have a single SKU in production and the individualization is taken care of at fulfillment. We maintain full traceability as well from raw material to test result via the UDI.

Our device is quite unique and does not fall easily into a single IVD catagory.
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