The Medical Device Handbook For Europe

Shalinee Naidoo

• Publisher: Arcler Press
• Year: 2023
• eBook ISBN:
  9781774696842
• Topic: Medicine
• Subtopic: Internal Medicine & Diagnosis

As the medical device landscape continues to evolve, so does the regulatory framework in Europe. Through this process many gaps and scarcity of skills and expertise have also been identified. For this reason, there was an increasing need to update the current medical device directive (MDD 93/42/EEC) being used within the European Union. This in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). The release of the new Medical Device Regulation (EU MDR 2017/745) in 2017 marked the start of a three-year transition period for various Economic Operators along the supply chain. This volume aims to provide a simple overview of the medical device industry in Europe with particular focus on the main aspects covered in the new European Medical Device Regulation. Important concepts such as essential phases in a device lifecycle, complying to standards and regulations, the CE mark process and classification of medical devices in Europe are covered.

Table of contents

• Cover
• Title Page
• Copyright
• ABOUT THE AUTHOR
• TABLE OF CONTENTS
• List of Figures
• List of Tables
• List of Boxes
• List of Abbreviations
• Preface
• Chapter 1 Introduction to Medical Devices
• Chapter 2 Introduction to the Medical Device Market
• Chapter 3 Developing a Medical Device
• Chapter 4 Standards and Regulations
• Chapter 5 Regulating Medical Devices
• Chapter 6 Regulating Medical Devices in Europe
• Chapter 7 The Medical Device Directive (MDD 93/42/EEC)
• Chapter 8 Transitioning From the MDD to the MDR
• Chapter 9 Classification of Medical Devices in Europe
• Chapter 10 Safety and Performance of Medical Devices
• Chapter 11 Biocompatibility Testing
• Chapter 12 Easy Review Questions Around Biocompatibility Testing
• Chapter 13 Economic Operators
• Chapter 14 Person Responsible for Regulatory Compliance
• Bibliography
• Index
• Back Cover