European IVDR PDF + Table of Contents for 2017/746
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.
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)
|Making available on the market, and putting into service of devices, obligations of economic operators, CE Marking, free movement|
|Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance, European database on medical devices|
|Classification and conformity assessment|
|Clinical evidence, performance evaluation and performance studies|
|Post-market surveillance, vigilance and market surveillance|
|Cooperation between member states, medical device coordination group, EU reference laboratories and device registers|
|Confidentiality, data protection, funding and penalties|
|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?
The Oriel STAT A MATRIX team of IVD specialists can assist 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!