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.
It 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.
Discover the EU MDR Guidebook here.
The EU IVDR Guidebook
A comprehensive reference resource for In Vitro Diagnostic Device manufacturers operating or selling devices in the EU.
▪ 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
RAPS IVDR eBook
We have teamed up with the Regulatory Affairs Professionals Society (RAPS) to offer our IVDR book in a convenient e-Book format.
This IVDR e-Book provides the exact same comprehensive analysis in 376 pages on how to apply the IVDR requirements to your business.