European IVDR PDF + Table of Contents for 2017/746

January 17, 2019

Weighing in at 157 pages and 85,000 words, the new European IVD Regulation requires serious concentration for regulatory professionals.

We’ve made this daunting task a little easier by adding a fully linked, easy-to-navigate Table of Contents to the IVDR. Just download the IVDR PDF and save it to your desktop for quick reference.

IVDR Table of Contents

Inside the EU IVDR PDF (2017/746), you’ll find quick links to every Chapter, Article and Annex. If you are new to IVD regulation in Europe (or even if you are not), you may want to consider our three-day immersive training class on the IVDR changes.

Contents of the IVDR (2017/746)

Chapter I
(Articles 1-4)
Introductory provisions
Chapter II
(Articles 5-21)
Making available on the market, and putting into service of devices, obligations of economic operators, CE Marking, free movement
Chapter III
(Articles 22-30)
Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance, European database on medical devices
Chapter IV
(Articles 31-46)
Notified bodies
Chapter V
(Articles 47-55)
Classification and conformity assessment
Chapter VI
(Articles 56-77)
Clinical evidence, performance evaluation and performance studies
Chapter VII
(Articles 78-95)
Post-market surveillance, vigilance and market surveillance
Chapter VIII
(Articles 96-101)
Cooperation between member states, medical device coordination group, EU reference laboratories and device registers
Chapter IX
(Articles 102-106)
Confidentiality, data protection, funding and penalties
Chapter X
(Articles 107-113)
Final provisions
Annex I General safety and performance requirements
Annex II Technical documentation
Annex III Technical documentation on post-market surveillance
Annex IV EC declaration of conformity
Annex V CE Marking of conformity
Annex VI Information to be submitted upon the registration of devices and economic operators in accordance with articles 26(3) and 28, core data elements to be included in the UDI database together with UDI-DI in accordance with Articles 25 and 26 of the UDI system.
Annex VII Requirements to be met by Notified Bodies
Annex VIII Classification rules
Annex IX Conformity assessment, based on a quality management system and on assessment of technical documentation
Annex X Conformity assessment based on type examination
Annex XI Conformity assessment based on production quality assurance
Annex XII Certificates issued by a notified body
Annex XIII Performance evaluation, performance studies and post-market performance follow-up
Annex XIV Interventional clinical studies and certain other performance studies
Annex XV Correlation table (with the IVDD)

Need help understanding the EU IVDR changes and creating a transition strategy?

Our IVDR implementation class will give you the foundational knowledge to understand what’s required and how to tackle it. If you’re an auditor, consider this class instead. The Oriel STAT A MATRIX team of IVD specialists is also ready to help you with a variety of issues related to the new In Vitro Diagnostic Regulation. This includes IVD classification, gap assessments, IVDD to IVDR transition strategy, technical documentation, clinical data, risk management or ISO 13485 implementation

Please contact us to let us know how we can help you!

Our team is here to help. Call 1.800.472.6477 or contact us online ›