UDI for custom-made device

ttylda

Starting to get Involved
Hello,

I would like to ask whether the UDI code for implantable, custom-made medical devices is required. We've just started the certification process for EN ISO 13485. The auditors claimed that we should have it, as in Annex VII, 6. (Rules for specific device types) enlists implantable devices.

I am confused. Thus, Annex XIII of MDR doesn't mention the UDI code to be put in the statement. Morever, Art. 27. of the MDR a few times excludes CMD devices from the scope of the chapter. Even Art. 29. excludes CMD from assigning Basic UDI-DI before placing the device on the market. Can I justify the exemption for setting UDI for CMD by using the above-mentioned examples?

As part of the identification and traceability process, we use an assigned enumeration for each design (order). That is used during each step of the manufacturing process and labelling as well.

Kind regards
 
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