PSUR web form

The web form carries the administrative data on the device, the manufacturer, the notified body and the PSUR process, while the PSUR itself holds the analysis. Filling it in consistently helps match each PSUR to the right devices.

PSUR Web Form: Template that contains all the information that will be available in Eudamed for the PSUR. This form details information regarding the medical device, manufacturer, NB and the management of the PSUR process.

MDCG 2022-21, Section 1.2, Terminology