Course Description

Introduction to the EU Regulatory System

Course Description:

This course reviews the classification levels within European medical device directives, including related regulatory requirements and routes to the CE-mark. It emphasizes the need for good documentation practices and the required technical file setup and maintenance throughout the medical device lifecycle.

This course also highlights the importance of quality systems and how the design and early setup of one can help manufacturers ensure compliance and improve efficiency.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

  • Identify where information on medical device regulatory and product development requirements is found
  • Comprehend how the EU Regulatory System works and the different parties involved
  • Recognize the differences between pharmaceutical and medical device systems

Who Should Enroll:

Professionals new to the medical device industry, including inventors, managers, CEOs, or professionals wanting an overview of the global lifecycle of medical devices are all encouraged to enroll in this course.

Prerequisite Knowledge/Requirements:

The following course is required:

  • The Lifecycle of Medical Devices from Idea to Market (ID 159)

Subject Matter Expert:

36 min

Related resources:

Case studies:

Basic Account: € 106.00
Premium Account: € 80.00

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