EU Medical Device Regulation (EU MDR) – Chapters 1 to 5

Home » EU Medical Device Regulation (EU MDR) – Chapters 1 to 5

Description:

The objective of this course is to provide you with an overview of the EU MDR 2017/745. This overview will guide you through the following the background of the EU MDR, why it was introduced, the EU MDR structure and timeline, the main differences between MDD and MDR, an overview of each chapter and some of the key challenges facing organizations due to its introduction. It is designed to provide the student with a high-level comprehension of the regulation and what it means for organizations in today’s world of medical device manufacture.

Curriculum for this course:

Introduction

Overview Introduction	1 min 01 secs
Learning Objectives for this Overview	1 min 31 secs
The Background of the EU MDR 2017/745	1 min 25 secs
1901 – Jim the Horse Tetanus Scandal	1 min 25 secs
1959 – Primodos	58 secs
1996 – ISO 13485 Medical Devices — Quality Management Systems	1 min 09 secs
2018 – Vaginal Mesh Implants	1 mins 10 secs
A Regulatory Evolution	1 mins 22 secs
Introduction to EU MDR	1 mins 17 secs
The Regulation	53 secs
Chapters and Articles	1 mins 28 secs
Annexes	1 mins 31 secs
The EU MDR Timeline	55 secs
What this means	1 mins 14 secs
MDD vs MDR	57 secs
Chapters I to V	1 mins 10 secs

Chapter I

In Scope	1 min 15 secs
Out of Scope	1 min 10 secs
Definitions	48 secs

Chapter II

Placing on the market and putting into service	1 min 12 secs
Claims	1 mins 29 secs
Common Specifications	1 min 21 secs
General obligations of Manufacturers	59 secs
Authorized Representative	1 min 10 secs
General obligations of Importers	1 min 38 secs
General obligations of Distributors	1 min 30 secs
Person Responsible for Regulatory Compliance (PRRC)	1 min 11 secs

Chapter III

Medical Devices Nomenclature	1 min 15 secs
European Database	1 min 10 secs
Registration of Devices	56 secs
Unique Device Identification System	1 min 17 secs

Chapter IV

Authorities Responsible for Notified Bodies	1 min 11 secs
Requirements Relating to Notified Bodies	1 min 22 secs
Assessment of Application	1 min 07 secs

Chapter V

Classification of Devices	1 min 04 secs
Assessment of Conformity	1 min 14 secs
Certificate of Sale	1 min 30 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.