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After completing this module, you will be able to:


Summarize Active Implantable and In-vitro  medical devices as per the new EU MDR.


Explain the three directives on Medical devices i.e.  In Vitro Diagnostic Directive (IVDD) - 98/79/EC, Medical Device Directive (MDD) - 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) - 90/385/EEC.


Discuss the transformation of old EU directives into new regulations with relationships.


Demonstrate your understanding on the background of important regulatory changes along-with with the implementation aspect of the new regulations.


Evaluate your understanding on the important terms and definitions, given in the new EU MDR. 


Outline the publication aspects of the EU MDR.


Summarize the important improvement with the new EU MDR.


Explain the timelines of the enforcement of the EU MDR.