UDI - Unit of Use and Class I, single-use devices

#1
Can anyone offer any clarity on the MDR UDI requirements for Class I, single use devices, and specifically details around the Unit of Use DI?
If you have multiple devices packed in a plastic bag (with the bag being the base level of packaging), my understanding is that this bag will be labelled with the UDI and UDI carrier (barcode), and then each higher level of packaging (e.g. a carton) will also then be marked with its own unique UDI. Am I correct in stating that each individual device (if class I and single-use) does not need to be marked with the UDI carrier as per Annex Vi, Part C, 4.3?
If this is the case however, do we still need to generate and store a Unit of Use DI for each individual device?
According to the MDR definition “The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.” So, if we take a box of 20 adhesive plasters as an example, does the MDR definition mean that each individual plaster will need a UoU DI recorded and stored by the manufacturer (to associate the plaster with a patient), although not required to be marked on the plaster itself? What would the UDI comprise of on the box of 20 plasters?
I appreciate any clarity that can be given on this.
 
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Kat C

Registered
#4
Hi, FlatJF
I agree with rob73's recommendation to use GS1, though I usually look at the global gs1.org website. The GS1 Healthcare GTIN Allocation Rules particularly can help. In your situation, where Annex VI, Part C, 4.3 applies, you apply the UDI on your base packaging, the bag or box in your examples, which is called the "each" in GS1 terms. The individual device is assigned a Unit of Use DI, but I think the part you're missing is that the Unit of Use DI is assigned to "the device", not "each device". This is a DI (Device Information), not PI (Production Information), and there is one UoU DI that is assigned the same to all your units, although it does not appear on the unit.
One thing I don't understand as far as hospital use of the UDI is how the UoU "serves to associate the use of a device with a patient" when it doesn't appear on the labeling. I would assume that the device user would enter the UDI that he sees (on the bulk device packaging) into the patient's health record.
 

Kat C

Registered
#5
Hi, FlatJF
I agree with rob73's recommendation to use GS1, though I usually look at the global gs1.org website. The GS1 Healthcare GTIN Allocation Rules particularly can help. In your situation, where Annex VI, Part C, 4.3 applies, you apply the UDI on your base packaging, the bag or box in your examples, which is called the "each" in GS1 terms. The individual device is assigned a Unit of Use DI, but I think the part you're missing is that the Unit of Use DI is assigned to "the device", not "each device". This is a DI (Device Information), not PI (Production Information), and there is one UoU DI that is assigned the same to all your units, although it does not appear on the unit.
One thing I don't understand as far as hospital use of the UDI is how the UoU "serves to associate the use of a device with a patient" when it doesn't appear on the labeling. I would assume that the device user would enter the UDI that he sees (on the bulk device packaging) into the patient's health record.
FlatJF, one more thing: Make sure that Annex VI, Part C, 4.3 applies, because your description doesn't completely match the exception: For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices. However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.
You mentioned multiple devices packed in a bag, whereas this exception has devices packaged and labeled individually. I actually have found no exception that allows for having multiple devices in a bag that are not packaged and labeled individually. If you've found anything like this, I'd be grateful for the reference.
 
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