2016, July

The regulatory landscape for In Vitro Diagnostics (IVDs) in Europe is expected to go through some significant changes in the coming months, with the replacement of the IVD Directive by the IVD Regulation. When for some, those changes constitute a significant evolution, for other, it is a revolution. In all cases, IVD manufacturers should be prepared to understand, undertake and comply with the future requirements of the IVD regulation and familiarize themselves with the requirements on Clinical Evaluation.

While entering the critical phase of the trilogue, critical changes have emerged from the requirements and will strongly impact the IVD industry. Among those, we note new requirements for Clinical Evidence / Performance Evaluation and Studies. IVD Manufacturers need to determine the proper studies for existing and future IVD devices to ensure for a smooth transition.

Join LNE/G-MED and Dr. Julien Sénac for an introduction to the Clinical Evaluation Requirements for IVDs. Julien will discuss some of the more important changes expected to be introduced with the IVD regulation, and their future impact for IVD manufactures and their products.

In this webinar, you will learn about:

  • Clinical Evaluation / Performance studies requirements in the IVDR
  • Similarities in Performance requirements between the IVDD and IVDR
  • Requirements for currently CE marked IVD products
  • Scenarios of performance studies for different IVD products under the new IVDR


Julien SENAC Certification Project Manager IVD Technical file and Design Dossier assessor - LNE/G-MED

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