Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic Devices Directive (98/79/EC), which dates from 1998, has been thrown out the window and will be replaced by the IVDR 2017/746.
What has changed? A lot. The IVDR will be an entirely new classification scheme for IVDS; it places far more emphasis on clinical data and risk management, and expands conformity assessment requirements to 80% of IVD companies. Those are big changes.
TOPICS COVERED
- Framework and overview of IVDR
- IVD classification scheme
- Companion diagnostics
- Conformity assessment and Notified Body involvement
- Emphasis on traceability, vigilance and PMS
- Clinical evidence requirements
- Responsibilities of importers and distributors
Recorded November 2016
ABOUT THE PRESENTER
Dr. Oliver Eikenberg (RAC) is a Senior Regulatory Consultant for Emergo based in Germany. He is an expert in In Vitro Diagnostic devices and previously held QA/RA positions with SYSMEX Inostics, IBL International, Human Biochemica and Diagnostica, ABETA and The Genetics Company. He holds a Ph.D. in Chemistry and Biochemistry from the Technical University of Munich.
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Understanding Europe's New In Vitro Diagnostic Medical Devices Regulation
The European Commission's new In Vitro Diagnostic Regulation (IVDR) will address several weaknesses of the IVDD and bring significant regulatory changes for IVD manufacturers selling in Europe. Application is predicted for 2022, but proactive IVD companies are beginning to plan their implementation strategy now. In this white paper, Emergo takes an in-depth look at the IVDR and answers your biggest questions about Europe's changing regulatory landscape. Download now.