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.
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.