The New European UDI System Part II


The second part of New European UDI System Video Course is designed to help you discover UDI Implementation, Medical Device Registration, and functional specifications. This course also covers the data dictionary for UDI as well as the MDCG guidelines on UDI-DI and for special cases of device registration.

  • Course Type: Video Lessons
  • Language: English
  • Level: Advanced
  • Session: 2022
  • Time: 0 - 1 Hour
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Course Breakdown

Section Time
Introduction 00:01:18
UDI Implementation: Where are we? 00:00:32
Where and How to register your medical device 00:08:05
Examples of UDI Software for medical devices 00:02:28
EU Commission Eudamed Functional specifications for UDI 00:00:29
UDI Data dictionary published by EU Commission 00:01:09
Basic UDI-DI attributes published by EU Commission 00:00:27
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED 00:00:45
MDCG Guidance on basic UDI-DI and changes to UDI-DI 00:02:29
MDCG Guidelines for special cases of device registration 00:06:25

Exam and Certifications

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