The European In Vitro Diagnostic Regulation
Table of Contents
CHAPTER 1: Welcome
CHAPTER 2: Background to the IVDR
CHAPTER 3: How to use this guidebook
CHAPTER 4: Compliance guide
CHAPTER 5: Device Classification 21
CHAPTER 6: Performance Evaluation
CHAPTER 7: Conformity Assessment Route & Annexes
CHAPTER 8: QMS Tables
CHAPTER 9: Timelines
CHAPTER 10: IVDR Overview - Articles
CHAPTER 11: IVDR Overview - Annexes
CHAPTER 12: Indexes & Look Ups
CHAPTER 13: People 355
CHAPTER 14: MDCG Guidance
Meddev Solutions, Publisher
About the Book
Available formats: print and e-book
RAPS has teamed up again with Meddev Solutions to offer a practical guide to implementing the EU IVDR. Focusing on the new European regulation and how to apply the requirements into your business, the guidebook provides tools such as QMS checklists, performance evaluation checklists and other useful information to help you understand what is required. Designed as a reference guide, the book is broken into sections that can be quickly navigated through, giving reference to the original EU IVDR text and what requirements must be met. It does not replace the EU IVDR text, which should be used in conjunction with this guidebook.
Who will benefit from this book?
This guidebook was developed for anybody needing to understand what the EU IVDR may mean to them and is primarily focused on manufacturers of in vitro diagnostic devices.
Purchasing Options
This book can be purchased in the following formats:
- Digital e-book. Single purchase; accessible online via RAPS Library online reader and downloadable.
- Printed book.
This book can also be purchased as part of the following bundles:
- All Access Library (12-month digital subscription)
Published by RAPS © 2020. Paperback. 375 pages. ISBN: 978-1-9999876-3-3.
