The New European UDI System Part I


This lecture describes the key changes regarding post market surveillance and what companies should do to meet their new obligations. After the course you can take a final test to receive your certification. Enjoy!

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

Section Time
Introduction 00:02:29
MDR References & UDI Purpose and Benefits 00:01:50
UDI Components 00:02:42
Basic UDI-DI and Unit of Use DI 00:03:26
Information to be entered in EUDAMED 00:05:52
MDR Timelines for registration of device data in EUDAMED 00:00:45
Correlation table between MDD and MDR 00:00:50
UDI in Europe vs the USA 00:07:11

Exam and Certifications

  • Final Test – MDR The New European UDI System (Part I)
  • Certification


What I will learn?

This course will highlight the UDI system and will facilitate easier traceability of medical devices and quick identification of the specific user. This system significantly enhances the effectiveness of the post-market safety-related activities for devices and allow for better monitoring by competent authorities.

Skills I will gain

  • Discover Unique Device Identification (UDI) System
  • Explore the UDI structure and requirements
  • Learn key the timelines for registration of device data for EUDAMED
  • Understand the difference between UDI in Europe vs the USA


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