New and emerging technologies as well as various well-known incidents within the medical device industry have challenged the current framework, highlighted gaps and pointed to a certain scarcity of skills and expertise. For this reason, there was increasing need to update the European Medical Device Directives. This has since led to the development and release of the Medical Device Regulation (MDR 2017/745) which has now put stricter regulatory controls on the entire product life cycle. Both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) contain a complete section on economic operators for medical devices. Although the manufacturer is ultimately responsible for ensuring their medical device is compliant with the relevant legislation, the various defined economic operators within the Regulation, now have a part to play in ensuring the safety and performance of the device throughout the supply chain. This new policy of sharing compliance is an important component of the MDR2017/745 with each economic operator serving as a control on the other, causing each device to receive a number of checks throughout the process before it is brought to market. In addition to this, it also allows for any compliance issues emerging from any one of the economic operators to have a direct legal implication on the other. Changes brought about by the MDR2017/745 in Europe require not only manufacturers but all defined economic operators to take a proactive, multilevel and multidisciplinary approach when it comes to ensuring safe and effective devices are placed on the market. This volume looks at each Economic Operator in greater details with their relevant responsibilities.
- 268 pages
- English
- PDF
- Available on iOS & Android
eBook - PDF
About this book
Trusted by 375,005 students
Access to over 1.5 million titles for a fair monthly price.
Study more efficiently using our study tools.
Information
Table of contents
- Cover
- Title Page
- Copyright
- ABOUT THE AUTHOR
- TABLE OF CONTENTS
- List of Glossary
- List of Figures
- List of Tables
- List of Abbreviations
- Preface
- Chapter 1 The History of Medical Device Regulations
- Chapter 2 The CE Mark Process
- Chapter 3 Classification of a Medical Device
- Chapter 4 Quality Management System
- Chapter 5 Technical File/STED
- Chapter 6 Appointing an Authorized Representative
- Chapter 7 Declaration of Conformity
- Chapter 8 The Medical Device Directive 93/42/EEC
- Chapter 9 The Medical Device Regulation 2017/745
- Chapter 10 Economic Operators
- Chapter 11 Designating a Person Responsible for Regulatory Compliance
- Bibliography
- INDEX
- Back Cover
Frequently asked questions
Yes, you can cancel anytime from the Subscription tab in your account settings on the Perlego website. Your subscription will stay active until the end of your current billing period. Learn how to cancel your subscription
No, books cannot be downloaded as external files, such as PDFs, for use outside of Perlego. However, you can download books within the Perlego app for offline reading on mobile or tablet. Learn how to download books offline
Perlego offers two plans: Essential and Complete
- Essential is ideal for learners and professionals who enjoy exploring a wide range of subjects. Access the Essential Library with 800,000+ trusted titles and best-sellers across business, personal growth, and the humanities. Includes unlimited reading time and Standard Read Aloud voice.
- Complete: Perfect for advanced learners and researchers needing full, unrestricted access. Unlock 1.5M+ books across hundreds of subjects, including academic and specialized titles. The Complete Plan also includes advanced features like Premium Read Aloud and Research Assistant.
We are an online textbook subscription service, where you can get access to an entire online library for less than the price of a single book per month. With over 1.5 million books across 990+ topics, we’ve got you covered! Learn about our mission
Look out for the read-aloud symbol on your next book to see if you can listen to it. The read-aloud tool reads text aloud for you, highlighting the text as it is being read. You can pause it, speed it up and slow it down. Learn more about Read Aloud
Yes! You can use the Perlego app on both iOS and Android devices to read anytime, anywhere — even offline. Perfect for commutes or when you’re on the go.
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
Please note we cannot support devices running on iOS 13 and Android 7 or earlier. Learn more about using the app
Yes, you can access Understanding the Role of Economic Operators within the Medical Device Regulatory Sector by in PDF and/or ePUB format. We have over 1.5 million books available in our catalogue for you to explore.