PhaRegistrum · Originally published on 07/01/2026
Following Decision (EU) 2025/2371, four EUDAMED modules become mandatory for all actors involved with medical devices.
Although mandatory use begins in 2026, internal planning, process review and data preparation should start now to meet regulatory deadlines.
The modules are actor registration; device/UDI registration; notified bodies and certificates; and market surveillance.
PhaRegistrum supports the entire preparation and implementation process.
#PhaRegistrum
#EUDAMED
#MedicalDevices
#MDR
#RegulatoryAffairs
#Compliance
#DispositivosMédicos