How to classify your medical device under European Regulations

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• Publisher: Arcler Press
• Year: 2022
• Edition: 0
• eBook ISBN:
  9781774693667
• Topic: Law
• Index: Law

Over the last 20 or so years, the number, range, and complexity of medical devices available on the market has increased drastically and as a result, so has the complexity of the regulations involved. With new and emerging technologies as well as various well-known incidents within the medical device industry, the current regulatory framework has since been challenged. In fact, many gaps and scarcity of skills and expertise have been identified. For this reason, there was an increasing need to update the current Medical Device Directive (MDD 93/42/EEC) in the European Union, which in turn led to the development and release of the Medical Device Regulation (EU MDR 2017/745). This volume aims to provide an easy-to-understand guide for beginners to the medical device regulations in Europe with specific focus on classification methods. It looks specifically at how to class a medical device based on the risk associated with it as well the details around the European Classification Systems provided in the MEDDEV 2.4/1. This volume also delves into the detail around defining borderline medical devices and how they are classified according to the Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices as published by the European Commission.

Table of contents

• Cover
• Title Page
• Copyright
• ABOUT THE AUTHOR
• TABLE OF CONTENTS
• List of Figures
• List of Tables
• List of Box
• List of Abbreviations
• Introduction
• Preface
• Chapter 1 Introduction to Medical Devices
• Chapter 2 Medical Device Use and Regulation
• Chapter 3 Overview of the CE Mark Process
• Chapter 4 History of Medical Devices
• Chapter 5 The Medical Device Directive 93/42 EEC
• Chapter 6 The Medical Device Regulation MDR 2017/745
• Chapter 7 Overview of Medical Device Classification
• Chapter 8 Understanding the EU Guidelines on Medical Device Classification
• Chapter 9 Understanding EU Classification Rules under the MDR 2017/745
• Chapter 10 Medical Device Nomenclature
• Bibliography
• Index
• Back Cover