MDR要求设备本体打UDI吗？

huhu01

可重复使用的检测设备。设备特别小，都没有空间打UDI。有什么解决办法吗？
只在最小包装的包装盒上打UDI，设备本体没有，符合要求吗？

bangzhibing

UDI一般打在标签上吧，不用打在设备上

TOMDengovu

这个需要查看MDR中关于UDI章节的要求，3.1条款明确说明了：A UDI shall be assigaed to the device itself or its packaging.higher levels of packaging shall have their own UDI

huhu01

bangzhibing 发表于 2022-9-9 15:11
UDI一般打在标签上吧，不用打在设备上

我是指设备本身的标签，设备太小了打不下

feignte

法规里这两条应该适用。
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.


If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label. For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.

Wendy0919

TOMDengovu 发表于 2022-9-9 15:27
这个需要查看MDR中关于UDI章节的要求，3.1条款明确说明了：A UDI shall be assigaed to the device itself  ...

包装上确定也可以吗，请问

Neuro_psycho

法规有明文规定的  楼上的就是正解

TOMDengovu

Wendy0919 发表于 2022-9-9 18:04
包装上确定也可以吗，请问

是的，按照法规走就对了

九o040vmij

按照法规走就行啊

viola0216

feignte 发表于 2022-9-9 17:47
法规里这两条应该适用。
Devices that are reusable shall bear a UDI carrier on the device itself. The ...

TKS FOR SHARING