研讨会和活动
Direct marking
The manufacturer should define the format, specifications and location of the UDI Carrier on the label or permanent marking (if and when required on the device) in compliance with Annex VI Part C, Section 4.10 of the MDR/IVDR:
"Devices that are reusable shall bear a UDI carrier on the device itself. The UDI carrier for reusable devices that require cleaning, 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 requirement of this Section shall not apply to devices in the following circumstances:
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Any type of direct marking would interfere with the safety or performance of the device.
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The device cannot be directly marked because it is not technologically feasible.
The manufacturer should implement a procedure for placing the UDI Carrier on the label and if appropriate to directly mark the device.
Procedures to place UDI Carriers on the label and if appropriate directly on the device, should cover the general requirements as well as those for specific device types (e.g. implantable, systems and procedure packs, configurable devices, software as medical device).
Durability of the UDI marking during normal use of the device and the whole lifetime of the device should be ensured.