Medical Device Regulation Roadmap And Orientation


This lecture presents the roadmap of the new European regulation for medical devices and provides an orientation to navigate all the key changes. Learn all you need to know for a successful transition to the new legislative framework.

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

Course Breakdown

Section Time
Introduction 00:01:48
Meditrial Expert Speaker and Tools 00:01:33
Key Changes in MDR 00:05:05
MDR Structure 00:05:53
MDR Scope and Definitions 00:03:27
Economic Operators 00:07:47
EUDAMED and UDI 00:05:31
Classification & Conformity Assessment 00:02:09
Clinical Evaluation and Investigations 00:19:05
Surveillance & Vigilance 00:02:12
Cooperation 00:02:15
Data Protection 00:01:43
Final Provisions 00:04:44
Conclusions 00:04:25

Exam and Certifications

  • Final Test – Medical Device Regulation Roadmap and Regulation
  • 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
  • Cooperation between the European Commission and new entities
  • Data protection requirements

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
  • On completion, you’ll earn a certificate by Meditrial, an internationally recognized ISO 9001 certified provider of medical and regulatory education


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