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Medical Device Regulation Roadmap And Orientation

$79.00

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.

Description

Why take this course

The new MDR 2017/745 will be enforced on May 26, 2021. That will result in more complex rules that will impact medical device manufacturers, operators, health professionals, and the public. This Meditrial Video Course explains the fundamental concepts of MDR and clarifies the impact of this regulation on medical device industry, conduct of clinical trials and market entry process in Europe.

What I will learn

  • MDR Structure and Key changes to the Regulation
  • MDR Scope and Definitions
  • Responsibilities and obligations of Economic Operators
  • EUDAMED and UDI
  • 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

     

    TOPICS

    • 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)

    • Final Test – Medical Device Regulation Roadmap and Regulation
    • Certification

    Additional information

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