遗留器械的符合性声明应该怎么写？

刘学pz1

MDD证书过期，还没有取得MDR证书，但是已经满足作为遗留器械的要求了，那这个时候的符合性声明应该按MDD的要求来写还是MDR，需要注意哪些信息呢？

深藏blueq0z

还是按MDD符合标准写

小蚂蚁ant

按照MDD写，不过后续可以更新。做好变更记录保持追溯性。For legacy devices, the Declaration of Conformity (DoC) needs to refer to the MDD or AIMDD, as applicable. The manufacturer may additionally declare conformity with Article 120 MDR confirming that the conditions laid down therein are fulfilled. Where the manufacturer updates its DoC to reflect changes regarding information provided in
the declaration (e.g. changes concerning the address, the authorised representative, or the validity date) the  manufacturer should add a reference to the DoC which was drawn up for the legacy device before 26 May 2021.  In addition, traceability of all versions of the DoC needs to be ensured.