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Essentials of European Medical Device Regulations (EU MDR) - 2017/745
In this free online course learn about the key aspects of the European Medical Device Regulations (EU MDR) - 2017/745.
Description
In this free online course Essentials of European Medical Device Regulations (EU MDR) - 2017/745 you will learn about the essentials of EU MDR that will introduce you to the updates and changes in the new regulations. The course covers old European directives on medical devices, active implants, in-vitro diagnotics devices and how these will be replaced with new regulations. The course also covers the classification scheme of medical devices and the risk-based critera for that.
The course begins by introducing you to the important improvements and significant changes in the EU MDR. The course then covers the economic operators in the sector and their increased responsiblities with this regulation. Next, it explains the Unique Device Identifier, and reporting mechanism of data through EUDAMED.
This course will be of great interest to those working in Quality or Continuous Improvement departments in a medical devices' industry, or if you're considering working in medical devices' sector as a future career, or if you’re a medical devices' professional seeking to learn about the European Regulations. So, start this free online course today and in just 3 hours you’ll be acquainted with the basics of the European Medical Device Regulations (EU MDR) - 2017/745.
Start Course NowModules
Introduction to European Regulations on Medical Devices
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Introduction to European Regulation on Medical Devices - Learning Outcomes
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The Three European Directives on Medical Devices
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The Important Regulatory Changes in the European Market
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Terms and Definitions
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Publication of EU MDR and Important Points
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Introduction to European Regulation on Medical Devices - Lesson Summary
Essential Components of the EU MDR
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Essential Components of EU MDR - Learning Outcomes
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Technical Documentation & Post-market Surveillance
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Classification of Devices and Route to Market
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Economic Operations & Clinical Evaluation
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Essential Components of EU MDR - Lesson Summary
Reporting Requirements and Identification
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Reporting Requirements and Identification - Learning Outcomes
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Unique Device Identifier (UDI)
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European Database on Medical Devices (EUDAMED)
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Reporting Requirements and Identification - Lesson Summary
Course assessment
Learning Outcomes
After completing this course you will be able to:
- Explain the three directives on medical devices: IVDD, MDD & AIMDD
- Discuss the transformation of old EU directives into new regulations, and their relationships
- Summarize the important improvements with the new EU MDR
- Differentiate the different classes of medical devices and the criteria 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
- Describe the applications and requirements of EU-UDI
- Specify the requirements on EUDAMED in EU MDR
Certification
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