Leading device

The leading device sets the PSUR's timeline and reference for the whole group. When several devices share the highest class, the manufacturer picks one and should explain the choice.

Leading device: The “leading device” in a group of devices covered by the same PSUR corresponds to the highest risk class device. In the case when there are several devices with the same risk classification, the manufacturer should assign a leading device.

MDCG 2022-21, Section 1.2, Terminology