Device Specific: Reprocessed, System/Procedure Packs, Kits
Are the UDI-DIs of a single-use reprocessed devices the same as the original devices?
No. The person responsible for reprocessing the single-use medical device should assign a new Basic UDI-DI and UDI. The person responsible for reprocessing the device should additionally record the UDI for the original product in their technical documentation and quality management system, to ensure traceability.
The exception is if the single use device is reprocessed in a health institution, in which case a new UDI is not required. However, other obligations apply, outlined further in MDR Art. 17(3).
Should a system or procedure pack be assigned its own UDI? Or can the UDI assigned to the devices in the system or procedure pack be used?
Yes, a System or Procedure Pack should have its own UDI assignment, separate from the individual devices in the System or Procedure Pack.
Where should the UDI carrier be placed on systems and procedure packs?
As a general rule, the UDI carrier for a system or procedure pack shall be affixed to the outside of the packaging.
Where the devices in a system are not packaged together, before placing the system on the market, the natural or legal person responsible should assign (identify) the system with a UDI, and ensure that the UDI carrier is affixed so that users may have access to it, including when the system is installed/is used or operating.
Further, each device within the system or procedure pack should, as a general rule, bear their own UDI carrier.
What is a kit and what are the UDI requirements applicable?
Kits are related to IVDs, while Systems & Procedure Packs generally relate to medical devices. Kits are defined as a “set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination, or a part thereof”.
Kits shall be assigned and bear their own UDI. As should any components of the kit that are medical devices in their own right and commercially available on their own.