Introduction to Medical Devices and their regulatory framework

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• Select section General

  General

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  After completing this course, you will be able to:

  • Understand key definitions of Medical Devices and in vitro diagnostics (IVDs)
  • Acquire knowledge about the regulatory framework of the Medical Devices and in vitro diagnostics (IVDs)
  • Follow the history of the Medical Devices and the regulatory framework
  • Understand the key principles for application of the Medical Devices
  • Describe the classifications of the Medical Devices and in vitro diagnostics (IVDs)
  • Understand the role of the Notified Body and Conformity assessment
  • Acquire knowledge about CE marking and re-certification

   

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• Select section Lesson 1: History of Medical Devices and their regulatory framework

  Lesson 1: History of Medical Devices and their regulatory framework

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  • Select activity 1. Introduction

    

    1. Introduction Page

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  • Select activity 2. History of Medical Devices

    

    2. History of Medical Devices Page

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  • Select activity 3. History of Medical Device regulatory framework in the EU

    

    3. History of Medical Device regulatory framework in the EU Page

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  • Select activity 4. History of Medical Device regulatory framework in the US

    

    4. History of Medical Device regulatory framework in the US Page

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  • Select activity 5. References

    

    5. References Page

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• Select section Lesson 2: The regulatory framework: definitions of Medical Devices and in vitro diagnostics (IVDs)

  Lesson 2: The regulatory framework: definitions of Medical Devices and in vitro diagnostics (IVDs)

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  • Select activity 1. The European Medical Device Regulation (EU) 2017/745 (MDR)

    

    1. The European Medical Device Regulation (EU) 2017/745 (MDR) Page

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  • Select activity 2. The European in Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR)

    

    2. The European in Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) Page

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  • Select activity 3. Additional Resources on MDR and IVDR

    

    3. Additional Resources on MDR and IVDR Page

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  • Select activity 4. References

    

    4. References Page

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• Select section Lesson 3: The regulatory framework: key principles of its application

  Lesson 3: The regulatory framework: key principles of its application

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  • Select activity 1. Classification of Medical Devices and IVDs

    

    1. Classification of Medical Devices and IVDs Page

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  • Select activity 2. Notified Bodies and Conformity assessment

    

    2. Notified Bodies and Conformity assessment Page

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  • Select activity 3. CE marking

    

    3. CE marking Page

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  • Select activity 4. Clinical evidence requirement for Medical Devices and IVDs

    

    4. Clinical evidence requirement for Medical Devices and IVDs Page

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• Select section Assessment

  Assessment

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    Assessment Quiz

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