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"A comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU"
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.
Background to the IVDR
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