About Lesson
Exercise Files
Introduction and Background
Welcome to the course! Before we begin, let's cover some of the essential background needed to get the most out of this course.
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Directives to Regulations
Learn how the EU shifted from medical device "Directives" to newer, more stringent "Regulations"
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EU Regulatory Pathway MDR 2017/745
Overview of the pathway to comply with the EU MDR
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Medical Device Assessment
Learn how to assess whether your product is considered a medical device in the EU
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Device Classification
Understand the importance of device classification, and see how to classify your device using practical examples
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Conformity Assessment Route
Learn about the different ways we can be assessed to show compliance with the MDR
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Quality Management System
Brief introduction to quality management systems and their role in MDR compliance
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Annex II Technical Documentation
We discuss each part of MDR Annex II related to our technical submission
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Post-Market Surveillance (Annex III Techincal Documentation)
See how the MDR introduces stricter requirements for Post-Market Surveillance
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Declaration of Conformity and CE Marking
We review the final steps for becoming MDR compliant
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Final Updates and Timelines
Get the latest updates and timelines on MDR transitions, including EUDAMED and some helpful tools
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