The obligation to prepare the PSUR starts from the date of application of the MDR, which is currently set for May 26, 2021. Periodic Safety Update Report depends on the risk class of the device.
Specifically, for Class IIa medical devices the PSUR must be prepared on a semi-annual basis and is reviewed by the notified body during the conformity assessment review. For Class IIb or Class III medical devices, the PSUR must be documented at least once a year.
PSUR preparation should continue throughout the life of the device even if the certificate for the device can be withdrawn.
Who will review the PSUR?
According to EU MDR 2017/745, the notified body must annually review the PSURs for class III and implantable devices. For class IIa and IIb devices, the write-down must be performed during the surveillance audit.
The Sampling Guide for Class IIa / Class IIb and IVDR Class B / Class C MDR Devices for Evaluation of Technical Documentation should be used through sampling.
Competent authorities may also request and review PSURs as part of their supervisory investigations, clinical trial reviews, and market surveillance activities. The results of their evaluation will / will not be added to the database.