Module 15 2022

19/05/2022

MDCG 2019-9 – Overview

• IFU: • Includes statement on how to locate SSCP in EUDAMED. • Includes the Basic UDI-DI •

Provides URL to the Eudamed public website: https://ec.europa.eu/tools/eudamed

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

13

SSCP Template

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

14

7