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Packaging levels
Packaging levels
For single-use devices of classes I and IIa medical devices and class A and class B IVD medical devices 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 to the higher level of device packaging, in cases such as in home healthcare settings, the UDI shall be placed on the packaging (of the individual device).
For devices exclusively intended for retail point of sale, the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.
If the UDI carrier is readily readable through the device’s packaging, or scannable as in the case of AIDC, the placing of the UDI carrier on the packaging shall not be required.
In the event of significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
Higher levels of packaging shall have their own unique UDI. Shipping containers shall be exempted from the requirement.
If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label.
Per Annex VI Part C of the 2017/745:
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Item 3.1: A UDI shall be assigned to the device itself or its packaging.
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Item 3.6: Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.
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Item 4.1: The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of packaging.
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Item 4.2: In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.
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Item 4.7: If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.
In addition, see for example the GS1 Gen Specs that states that all efforts should be made to mark the device itself whenever possible so that it can be identified without its packaging. That possibility would depend on the size of the device and the available space to mark it (i.e. barcode or HRI).
The solution provider should be able to determine whether printing system being used has the capability to print a barcode or HRI on the particular surface or small enough according to the technical specifications of the issuing agency. For example, for GS1 this would be Gen Spec v19.1 Section 5.6.3.2 GS1 DataMatrix symbol sizes. Otherwise, a marking on the package could be made.
The following videos may also assist.