EU MDR

EU Medical Device Regulation

In the world of medical devices, trust is the ultimate currency. This course explores the EU Medical Device Regulation (MDR) not just as a legal requirement, but as the “invisible shield” protecting patient lives. By examining real-world safety implications and the lifecycle of compliance, you will learn how your role in the regulatory process prevents the next crisis and ensures that medical devices remain a safety net, not a risk.

CEU Credits: 0.1
Course Code: ELM-320
Duration: 15 mins
Skill Level: Intermediate
Language: English
Final Exam: Yes
Certification: Yes
Version: V2.0
Effective Date: 12/15/2025

Curriculum for this course

Course Introduction
Is it a device?
From I to III
Software
Demonstrating fitness overview
General Safety and Performance Requirements (GSPR)
Conformity assessment
Notified Body involvement
Technical documentation
Clinical evaluation
Equivalence
Traceability overview
Economic operator roles
Eudamed registration
Unique Device Identification
Summary of Safety and Clinical Performance
Equivalence
Sustained compliance overview
Post-Market Surveillance
Trend reporting
Periodic Safety Update Report
Post-Market Clinical Follow-Up
Reporting timelines and Field Safety Corrective Actions
CE certificate renewal
Summary
Test Your Knowledge
v2.0 Major update on 02/13/2026 This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
v1.0 Course released in 09/06/2021

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