EU Medical Device Regulation (EU MDR) – Introduction

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Description:

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.

Curriculum for this course:

Introduction

Program Introduction	1 min 01 secs
Program Contents	1 min 30 secs
Module Introduction	1 min 21 secs
Learning Objectives	1 min 15 secs
Introduction to EU MDR	1 min 40 secs

History of EU MDR 2017/745

Key Events and Timeline	1 min 05 sec
1901 – Jim the Horse Tetanus Scandal	1 min 45 secs
1906 – Pure Food and Drug Act	1 min 08 secs
1937 – Elixir Sulfanilamide Mass Poisoning	1 min 17 secs
1957 – Thalidomide	1 min 48 secs
1964 – The Yellow Card Scheme	1 min 02 secs
1971 – The Dalkon Shield	1 min 10 secs
1990 – FDA Device Recall Report	1 min 08 secs
1996 – ISO 13485 Medical Devices – QMS	1 min 05 sec
1997 – Food and Drug Administration Modernization Act	1 min 14 secs
2009 – Poly Implant Prothèse (PIP) Breast Implants	55 secs
2010 – DePuy Hip Replacement Recall	1 min 30 secs
2012 – Stryker Modular-Neck Hip Stem Implants Recall	1 min 15 secs
2012 – Batteries of Pacemakers and Implantable Defibrillators	1 min 10 secs
2019 – Medtronic’s Product Recall of Implanted Cardiac Pacemakers	51 secs
2019 – Injectable Cosmetic Treatments	1 min 37 secs

A Regulatory Evolution

A Regulatory Evolution	1 min 20 secs
The Regulation	1 min 55 secs
Chapters and Articles	1 min 31 secs
Annexes	1 min 39 secs
Timelines	1 min 45 secs
What does this mean?	1 min 38 secs
MDD vs MDR	1 min 29 secs
Summary	1 min 11 secs

Conclusion

Final Assessment

Certification

Author:

Ian Nicholls

Director at Explic8

Ian is a Director with extensive knowledge and experience in the management, development, implementation, and operation of processes and systems within the pharmaceutical and medical device industries. His skill set includes: • EU MDR 2017-745 / 21 CFR 820 / ISO 13485 / ISO 9001.

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