January 12, 2023
New MDCG Guidance on Periodic Safety Update Report (PSUR) - What's in it for IVD Manufacturers?
The PSUR is one of the new European requirements for higher-risk medical devices and in-vitro diagnostic medical devices (IVDs). Read the blog with requirements for IVDs and how the MDCG guidance provides valuable insight into the expectations on scope, structure, and content of PSURs for IVD devices.
Tags
In-Vitro Diagnostics
IVDR
MDCG
PSUR
PMPF
Highlights