Module 1: Essential Components of the EU MDR

After completing this module, you will be able to:


Discuss all requirements technical documentation based on the class of the medical devices.


Explain the change in archiving period of the technical files.


State collection of data and management of files in Post-market Surveillance.


Differentiate the different classes of medical devices and the criterion for classification.


List the 22 Rules of product classification for a medical device.


Interpret the route to market for medical devices in Europe.


Evaluate the roles of different economic operators in EU.


Discuss the authority of Notified Body and Competent Authority in European Space.