QA/RA Consulting, Auditing & Training
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.
| 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) |
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!
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EU OfficeCork, Ireland
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Phone: +353 21 212 8530