Module 1: Reporting Requirements and Identification

After completing this module, you will be able to:


Interpret the graphical illustration on EU Unique Device Identifier (EU-UDI). 


Explain the elements of EU UDI such as human readable and machine readable forms.


Distinguish between UDI-DI Device Identifier and UDI-PI Production Identifier.


Describe the application of EU-UDI.


Specify the requirements on EUDAMED in EU MDR.


Outline the steps of implementation of EUDAMED.


Justify the reasoning of EUDAMED through the data provision.


Summarize the information elements which will be incorporated in EUDAMED.


Define the SRN, and interpret its application with respect to roles, locations and clients of an organization.