Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices

Name: Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices
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Learn the basic rules and principles of the EU In-Vitro Diagnostic Device Regulation in this free online course.

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Learning Outcomes

In this free course, you will learn how to:

List the requirements given in the EU IVDR for Notified Bodies
State the IVDR rules used to classify the in-vitro diagnostic devices
Identify the contents of the risk management file of an in-vitro diagnostic device
Explain the notion and the purpose of in-vitro diagnostic devices
Describe all the main requirements that must be fulfilled to get compliant with the EU IVDR
Indicate the major changes brought into the IVDD to convert it into IVDR
List the seven rules of IVDR required to classify the in-vitro diagnostic devices correctly
Outline the requirements for labeling in-vitro diagnostic devices
Distinguish between the In-vitro Diagnostic Directive (IVDD) and In-vitro Device Regulations (IVDR)
Recognize the labels commonly used with in-vitro diagnostic devices

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