How to identify a kit/system or procedure pack under UDI requirements in the EU and the US?

Modified on Wed, 28 Aug at 8:12 PM

First of all, the manufacturer has to determine under which category its device falls.

If they are systems/procedure packs/kits, then they 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/procedure pack/ the UDI carrier shall as a general rule be affixed to the outside of the packaging.

For more details, the US FDA has developed a detailed guidance that can be found here:https://www.fda.gov/media/95120/download