Introduction to Medical Device Regulation Roadmap & Orientation


This course presents an overview of the new European regulation for medical devices and provides key information regarding new changes within the MDR. Learn all you need to know for a successful transition to the new legislative framework.

  • Course Type: Video Lessons
  • Language: English
  • Level: Beginner
  • Session: year 2020
  • Time: 0 - 1 Hour

Course Breakdown

Section Time
Introduction 00:01:23
Classification of Medical Devices 00:01:50
MDR Definitions for Clinical Investigation 00:02:21
Types of Investigations 00:06:24
Clinical Evaluation and Investigation 00:02:12
Vigilance and Safety Reporting 00:02:47
Timelines and Grace Period 00:05:12
Conclusion 00:03:36

Exam and Certifications

  • Final Test – Introduction to Medical Device Regulation Roadmap & Orientation
  • Certification


What I will learn?

  • Fundamental Concepts regarding the new MDR
  • MDR Scope and Definitions
  • Key changes to clinical trials
  • Responsibilities and obligations of Economic Operators
  • Device classification and Conformity assessment
  • Clinical evaluation and investigations
  • Surveillance and Vigilance

Skills I will gain

  • Understand the principles, framework and procedures described in MDR
  • Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
  • Set a strategy to meet the new requirements and get your product to the market
  • Understand your responsibilities and obligations as a manufacturer, EU representatives, importers and distributors of medical devices Class I to III


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