The EU In Vitro Diagnostic Regulation Guidebook

The IVDR Guidebook provides practical tools and guidance for In Vitro Diagnostic Device manufacturers and anyone else with a need to understand exactly how to implement the IVDR.
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"A comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU"

376 Pages

14 Chapters

Only €255

The IVDR Guidebook distills the IVDR into meaningful chapters with a host of tools and tables that can be used to assist in complying with the requirements of the IVDR. This book is a reference guide, and as such, is not designed to be read from cover to cover.

It is broken into sections that can be quickly navigated through, giving reference to the original IVDR text and what requirements must be met. ​This book is part of the Meddev Solutions Guidebook Series, that offers practical application guidance to a number of topics that are important for device manufacturers to understand.

Guidebook Content

Background to the IVDR
Compliance guide 
Device Classification
Classification Rules
Performance Evaluation and Clinical Evidence 
Performance Evaluation report checklist  
Conformity Assessment Route & Annexes
ISO 13485 to IVDR requirement table
IVDR Article to ISO 13485 clause table
IVDR Annex to ISO 13485 clause table
Articles 1 - 113
Annex Overviews 
MDCG Guidance

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