Table of Contents for the EU MDR 2017/745
If you have downloaded the 175-page European Medical Device Regulation PDF but are frustrated that it does not contain a Table of Contents, Oriel STAT A MATRIX has come to your rescue. We have taken the official MDR regulation as published on May 5, 2017 and added a very easy-to-navigate clickable MDR Table of Contents – all in one single PDF.
We’ve added internal links so you can quickly access every Chapter, Article, and Annex!
Inside the Table of Contents for MDR 2017/745, you’ll find quick links to every significant section, including:
- Chapter I, Articles 1-4 – Scope and definitions
- Chapter II, Articles 5-24 – Making available on the market and putting into service of devices, obligations of economic operators, reprocessing, CE marking, free movement
- Chapter III, Articles 25-34 – Identification and traceability of devices, registration of devices and of economic operators, summary of safety and clinical performance, European database on medical devices
- Chapter IV, Articles 35-50 – Notified bodies
- Chapter V, Articles 51-60 – Classification and conformity assessment
- Chapter VI, Articles 61-82 – Clinical evaluation and clinical investigations
- Chapter VII, Articles 83-100 – Post-market surveillance, vigilance and market surveillance
- Chapter VIII, Articles 101-108 – Cooperation between Member States, Medical Device Coordination Group, expert laboratories, expert panels and device registrars
- Chapter IX, Articles 109-113 – Confidentiality, data protection, funding and penalties
- Chapter X, Articles 114-123 – Final provisions
- ANNEX I – General safety and performance requirements
- ANNEX II – Technical documentation
- ANNEX III – Technical documentation on post-market surveillance
- ANNEX IV – EU declaration of conformity
- ANNEX V – CE marking of conformity
- ANNEX VI – Registration of devices and economic operators; UDI
- 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 product conformity verification
- ANNEX XII – Certificates issued by a notified body
- ANNEX XIII – Procedure for custom-made devices
- ANNEX XIV – Clinical evaluation and post-market clinical follow-up
- ANNEX XV – Clinical investigations
- ANNEX XVI – List of groups of products without an intended medical purpose
- ANNEX XVII – Correlation table showing Council Directive 90/385/EEC, Council Directive 93/42/EEC and the MDR
Need help understanding what to do next?
If you need help with MDR transition strategy, gap assessments, or simply getting up to speed quickly on the MDR requirements, check out our MDR training and consulting options. Oriel STAT A MATRIX has been assisting medical device companies with QA/RA compliance for decades and we can help you smoothly transition to the MDR.