The EU In Vitro Diagnostic Regulation Handbook

The IVDR Guidebook distils 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 Trinzo Solutions Guidebook Series that offers practical application guidance to a number of topics that are important for device manufacturers to understand.

What’s Included

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

The EU In Vitro Diagnostic Regulation Handbook

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

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€255