MDR Fundamentals


Welcome to the Meditrial MDR Fundamentals. In three easy VIDEO-COURSES, you will learn all the essential information regarding the MDR changes and the new procedures for Clinical Evaluation and clinical trials, including a learning module on the new standard 14155. Get ready to learn all you need to know on the new European regulation for medical devices. After the courses, you can take a brief test to receive your certification. Enjoy!

  • Course Type: Video Lessons
  • Language: English
  • Level: Intermediate
  • Session: year 2020
  • Time: 1 - 3 Hours

Course Breakdown

Section Time
MDR Roadmap and Orientation Program 00:58:00
Clinical Evaluation 2020 00:39:00
New ISO 14155:2020 Key Changes for Your Trial 00:15:00

Exam and Certifications

  • Final test for MDR Roadmap (EU 101-A)
  • Final test for Clinical Evaluation 2020 (EU 110)
  • Certification


What I will learn?

  • MDR Structure and Key changes to the Regulation
  • MDR Scope and Definitions
  • 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 the scope and definitions followed by economic operators
  • Learn how MDR regulates the manufacturing and marketing of medical devices in the EU
  • Understand clinical evaluation and investigations along with surveillance and vigilance of medical devices.


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