UDI

圈圈里12

MDD证书好多年了一直没有推过外贸，现在要推，对于MDD证书需要再EUDAMDE上传UDI吗，MDR是需要的，MDD的要吗

赵琪efz

MDD如果当时没有转换或者延续就 失效了···

深藏blueq0z

MDD证延续了吗，MDD好像也是需要上EUDAMDE

圈圈里12

赵琪efz 发表于 2025-6-17 09:39
MDD如果当时没有转换或者延续就 失效了···

延续了，每年都在维护，年审，要转MDR了

赵琪efz

我们可以私信，希望可以帮到你。

warsong

MDCG 2021-25要求
As Article 10(9), point (h), of the MDR does not in itself establish a requirement for UDI assignment, the verification of UDI assignments only applies where UDI assignment is actually required for the relevant devices. As mentioned in MDCG 2019-5, ‘legacy devices’ are not subject to the MDR UDI requirements. This approach has not changed through Regulation 2023/60714.
MDCG 2019-5
The MDR is not explicit in requiring that these “legacy devices” are subject to relevant UDI obligations. The MDR device registration requirements (Annex VI Part A Section 2 and Part B that are complementary) make the Basic UDI-DI and UDI-DI the access keys for device-related information in the future Eudamed, which is reflected in the database design. Therefore, any registration of a device is normally possible in Eudamed only if a proper Basic UDI-DI and UDI-DI are assigned to the device and registered in the database together with the other device-related data.  
结论：不需要