Annually (first PSUR for legacy devices)

MDCG 2022-21 uses this reading to settle when legacy devices had to produce their first PSUR. It is mainly relevant when checking the PSUR history of a legacy device during an audit.

The term “annually” for drawing up the first PSUR for legacy devices should be understood as occurring during the course of the calendar year following MDR date of application.

MDCG 2022-21, Section 1.2, Terminology