M
mare1
I have a question regarding UDI label for reusable accessories...
According to PART C, Annex VI of MDR there is a requirement
On the other hand there is a requirement in the same Annex:
Those requirements are contradictory, aren't they?
How do you explain this?
Thank you
According to PART C, Annex VI of MDR there is a requirement
Does it mean that there are two possibilities - to place UDI on device itself or on its packaging even if it is possible to (for example) engrave the qr code on the device itself?3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
On the other hand there is a requirement in the same Annex:
4.10. 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: (a) any type of direct marking would interfere with the safety or performance of the device; (b) the device cannot be directly marked because it is not technologically feasible.
Those requirements are contradictory, aren't they?
How do you explain this?
Thank you