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Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices
time1.5-3hrs
timebeginner level
EU IVDR (in-vitro Diagnostic Device Regulation) has been successfully implemented across the European Union. It contains a lot of new requirements and conditions with which manufacturers should comply. In this course, we have included the material that will enable you to help manufacturers achieve the required compliance. This course will teach you about all the essential rules, requirements, and device classifications.
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Fundamentals of EU IVDR Regulations for In-Vitro Medical Devices
Learn the basic rules and principles of the EU In-Vitro Diagnostic Device Regulation in this free online course.
EU IVDR (in-vitro Diagnostic Device Regulation) has been successfully implemented across the European Union. It contains a lot of new requirements and conditions with which manufacturers should comply. In this course, we have included the material that will enable you to help manufacturers achieve the required compliance. This course will teach you about all the essential rules, requirements, and device classifications.
checked1Course description
checked1Course module
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Module 1
6 Lessons
In-Vitro Diagnostic Medical Device Regulations - Foundations
This module explains the EU IVDR, a regulation imposed across the European Union to govern the major aspects of the manufacturing and import of in-vitro diagnostic devices. You will mainly learn about their classification, labeling, and compliance requirements. You will also learn about the rules used to categorize these devices.
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1.The Basis of EU IVD Regulations- Learning Outcomes
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2.European Medical Device Regulations - IVDD to IVDR
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3.Main Requirements for IVDR Compliance
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4.Rules for Classifying the In-Vitro Diagnostic Devices
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5.Risk Management and Labeling Requirements of IVDR
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6.The Basis of EU IVD Regulations- Lesson Summary
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Module 2
1 Lessons
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