Performance Evaluation – When, What and How to Prepare for EU IVDR

Performance Evaluation is an old concept known under the European In-Vitro Diagnostics Directive (IVDD), but in-vitro diagnostics manufacturers now face much stricter controls and elements for accurate documentation to verify when, what, why and how this is done for their subject IVD products. This webinar provides a practical guide that: 

  • Explains the Performance Evaluation concept introduced by IVDR 2017/746
  • Focuses on the interaction of elements required for manufacturers to perform an adequate Performance Evaluation
  • Outlines when and how to perform Performance Evaluations for different IVD risk classes or IVD types
  • Explains the key aspects to consider for your product

 

Presenter:

Oliver Eikenberg, PhD
Senior Consultant, Quality and Regulatory Affairs
Oliver Eikenberg has over 17 years of medical device regulatory experience combined with technical hands-on experience in device development, manufacturing, and product management. Oliver’s background as a chemist with a PhD in analytical chemistry, combined with many years producing immunoassays, informs his expertise in in-vitro diagnostic devices. In his role as Senior Consultant, Oliver focuses on medical device regulations in the EU and the U.S., including Quality Management System implementations. He has managed several 510(k) submissions, performed 513(g) requests and Q-Sub (Pre-Sub) meetings with FDA, and reviewed and compiled multiple Technical Files for CE-marking in the EU for medical devices and IVDs. Oliver went through numerous Notified Body and FDA inspections in his medical device industry roles and as a senior consultant. He also acts as an internal auditor for Emergo by UL customers selling in Europe.

This webinar was recorded on April 21, 2022.