PMSV action

The term comes from the EUDAMED questions and answers and sorts which submissions can be made for which device groups. A PSUR goes to EUDAMED only for class III, implantable and class D Regulation devices, while vigilance reports also cover old, legacy and custom-made devices.

Post-market surveillance (a PSUR for a Class III or implantable or Class D Regulation device) or Vigilance related action (a report of a serious incident, periodic summary report or FSCA/FSN for an Old, Legacy, Custom-Made or Regulation Device, or a trend report for a Legacy or Regulation Device to EUDAMED)

Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed (Regulation (EU) 2024/1860), Abbreviations