Module 12 Presentations

29/01/2024

EUDAMED and its modules

Dec 2020

Oct 2021

Oct 2021

Economic Operators

Notified Bodies and Certificates •Notified Bodies •Summary of authorities investigations • Delivered,

Clinical Investigation

Market Surveillance

Devices

Vigilance and PMS

•Manufacturers •Authorized Rep •Importers •Procedure and System pack

•All devices

• Security

• Clinical

•Competent authority actions against non compliant devices • Preventive measures to protect public health

except custom made •For implants and class III, SSCP

datasheet •Vigilance reports and corrective actions •Trend reports •PSUR • Periodic Summary reports

investigation sponsor

•Report and summary • Clinical

withdrawn, suspended, refused certificates

investigation vigilance reporting

•SSCP

63

©Copyright Easy Medical Device GmbH

63

EUDAMED Public Page

64