EU: New guidances - among others for PSURs

The MDCG published several new and updated guidance documents, among these a PSUR guidance document.

MDCG 2022-19 and -20 detail the procedure for application for and changes to performance studies for IVDs. The updated MDCG 2022-4 covers the surveillance for legacy devices and MDCG 2022-21 contains information for the creation of PSURs.

Go back