Conformity assessment

The route depends on the device class and is set out in the regulation's annexes. For most devices above the lowest class it involves a notified body, and it ends with the declaration of conformity and the CE marking.

‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

EU MDR, Article 2(40)

‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled;

IVDR, Article 2(32)