Unit of use UDI-DI

flysky1117

Manufacturer Incident Report (MIR)for

Serious Incidents (MDR/IVDR)

and Incidents (AIMDD/MDD/IVDD)

今天填写这个文件遇到了一个问题

Unit of use UDI-DI:

这个位置应该填什么内容呢？

是使用方的 UDI-DI？

还是其他内容？

perilla

最小使用单位的DI

睿生生物赖坚鑫

perilla 发表于 2024-1-22 16:13
最小使用单位的DI

有最小使用单位的说法？不是只有最小销售单元吗，产品的UDI要体现在最小的销售单元上面

perilla

Unit of Use (UoU) UDI-DI
The UoU UDI-DI is an identifier assigned to an individual medical device. It is assigned in instances when a UDI is not labelled at the level of the device unit of use (e.g. several units contained in a plastic bag). Its purpose is to associate the use of a device to/on a patient.

你们啥标准都不看就报啊