Every two years (first PSUR for legacy devices)

MDCG 2022-21 places the first such PSUR in the second calendar year after the MDR date of application. It gives manufacturers of legacy devices a fixed reference point for the first report.

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

MDCG 2022-21, Section 1.2, Terminology