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The Meddev Solutions IVDR Guidebook
This European In Vitro Diagnostic Device Regulation Guidebook, is a comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
It distils the IVDR into meaningful chapters with a host of tools that can be used to assist in complying with the requirements of the IVDR.
This is part of the Meddev Solutions Guidebook Series, which 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.
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. However, it does not replace the IVDR text, which should be used in conjunction with this guidebook.