How should reusable devices be marked under EU MDR and IVDR?

Devices that are reusable shall bear a UDI carrier on the device itself.

The UDI carrier for reusable devices that require disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.

The requirements shall not apply to the device in case of the following circumstances:

• any type of direct marking would interfere with the safety or performance of the device;

• the device cannot be directly marked because it is not technologically feasible.