医疗器械MDR法规，医疗器械CE认证可追溯性（UDI）

提出器械的可追溯性（UDI）
1.除定制和研究器械外，其他器械均需建立UDI系统；
2.UDI信息体现在标签或包装上（不包含集装箱）；
3.UDI-DI信息需要载明于符合性声明中（见Article27）；
4.Annex VI Part B提出UDI-DI包含的信息；
5.可植入、重复使用、软件、可配置器械的UDI有特殊要求（见Annex VI Part C）
6.包装或标签上UDI实施的时间见Article123 (f)。
7.UDI 发行实体由欧盟委员会指定。
8.过渡性：Article 120指出“在委员会根据第27(2)条指定发行实体前，GS1、HIBCC和ICCBBA应被视为指定的发行实体”。

新的欧盟MDR认证对NB提出的严格要求
对“公告机构”，新版MDR花费大篇幅对其进行职能和要求进行描述；各NB需按照附录VII的要求重新申请MDR的三方审核的授权

Propose device traceability (UDI)

1. Except for customized and research devices, UDI system shall be established for other devices;

2. UDI information is reflected on the label or package (excluding containers);

3. UDI-DI information shall be stated in the declaration of conformity (see Article 27);

4. Annex VI Part B proposes the information contained in UDI-DI;

5. UDI with implantable, reusable, software and configurable devices has special requirements (see Annex VI Part C)

6. See Article 123 (f) for the implementation time of UDI on package or label.

7. UDI issuing entities are designated by the European Commission.

8. Transitional: Article 120 states that "GS1, HIBCC and ICCBBA shall be deemed as the designated issuing entities before the Commission designates the issuing entities in accordance with Article 27 (2)".

The new EU MDR certification imposes strict requirements on NB

For the "notified body", the new version of MDR spends a lot of time to describe its functions and requirements; Each NB shall reapply for the authorization of the MDR's tripartite audit according to the requirements of Appendix VII