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Is UDI (Unique Device Identifier) symbol mandatory under EU MDR?

Elsmar Forum Sponsor
#3
MDR covers UDI system will facilitate traceability of medical devices and significantly enhance the effectiveness of post market surveillance safety related activities. UDI system is not yet applicable for custom made devices and /or investigational devices. Manufacturer is responsible for complying with all UDI related requirements.
FDA- UDI is a requirement for device labelers ( manufacturers). If device is intended is more than one use, manufacturer is responsible to mark UDI on the device.
 
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