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Essentials of European Medical Device Regulations (EU MDR) - 2017/745
1.5-3hrs
beginner levelThis free online course explains the essentials of European Medical Device Regulations (EU MDR) - 2017/745. The course provides a way for learners to study the complex and detailed regulations, including the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors etc. This course will be interest to all professionals working in the medical devices' industry.
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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.
This free online course explains the essentials of European Medical Device Regulations (EU MDR) - 2017/745. The course provides a way for learners to study the complex and detailed regulations, including the improvements in the EU MDR, the technical files elements, post-market responsibilities, increased requirements related to market actors etc. This course will be interest to all professionals working in the medical devices' industry.
Course description
Course moduleA short ad will play before each lesson.
Module 16 Lessons
Introduction to European Regulations on Medical Devices
This module explains the existing relevant European directives for the medical devices' sector in Europe and how these will be replaced with the new EU regulations. The module further elaborates the important changes, improvements, and timelines of enforcement for the new regulations. The module also incorporates important terms from the EU MDR regarding industry.
1.Learning Outcomes
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2.The Three European Directives on Medical Devices
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3.The Important Regulatory Changes in the European Market
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4.Terms and Definitions
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5.Publication of EU MDR and Important Points
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6.Lesson Summary
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Module 25 Lessons
Essential Components of the EU MDR
Module 34 Lessons
Reporting Requirements and Identification
Module 41 Lessons
Course assessment
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