The manufacturer has to determine under which category its device falls.
System/procedure packs shall be assigned and bear their own UDI.
Device contents of system/procedure packs/kits shall bear a UDI carrier on their packaging or on the device itself.
The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.
The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.
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