Join us on Wednesday, June 29th, 2016, at 2 pm Eastern Time as LNE/G-MED North America Inc. will be hosting a free informative session on Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation
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.
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
Topic: Clinical Evaluation Requirements for In Vitro Diagnostic Devices (IVDs) in the upcoming IVD Regulation
About the presenter: Dr. Julien Sénac is an IVD specialist, Certification Project Manager and Technical Documentation Assessor for LNE/G-MED North America Inc.
Date: Wednesday, June 29th, 2016
Time: 2:00 pm Eastern Time Click here to Register!