EU MDR

EU Medical Device Regulation (EU MDR) – Introduction

This module is an introductory module to explain how, why and when the new regulations have come into force, what they consist of and some of the new and strengthened features. We will look at some of the historical events that have occurred over a period of decades and their consequences and we will be able to see the triggers for changes in legislation and understand what brought these changes about. This module includes a high-level overview of the contents of EU MDR 2017/745, some of the new features, the timelines for compliance and we’ll take a look at how the new MDRs compare to MDD.

CEU Credits: 0.1

Course Code: ELM-316

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Program Introduction

Program Contents

Module Introduction

Learning Objectives

Introduction to EU MDR

History of EU MDR 2017/745

Key Events and Timeline

1901 - Jim the Horse Tetanus Scandal

1906 - Pure Food and Drug Act

1937 - Elixir Sulfanilamide Mass Poisoning

1957 - Thalidomide

1964 - The Yellow Card Scheme

1971 - The Dalkon Shield

1990 - FDA Device Recall Report

1996 - ISO 13485 Medical Devices - QMS

1997 - Food and Drug Administration Modernization Act

2009 - Poly Implant Prothèse (PIP) Breast Implants

2010 - DePuy Hip Replacement Recall

2012 - Stryker Modular-Neck Hip Stem Implants Recall

2012 - Batteries of Pacemakers and Implantable Defibrillators

2019 - Medtronic’s Product Recall of Implanted Cardiac Pacemakers

2019 - Injectable Cosmetic Treatments

A Regulatory Evolution

A Regulatory Evolution

The Regulation

Chapters and Articles

Annexes

Timelines

What does this mean?

MDD vs MDR

Summary

Conclusion

Final Assessment

Certification

Author

Ian Nicholls

Director at Explic8

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