How the IVDR Impacts Intended Purpose and Classification

In this webinar, our Emergo by UL expert outlines the latest updates on how the IVDR impacts intended purpose and classification.

THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Watch now: How the IVDR impacts intended purpose and classification

Intended purpose is one of the main elements for discussion with Notified Bodies. In this webinar, the presenter will describe the impacts of intended purpose on an IVD manufacturer’s performance evaluation and technical documentation.

Webinar date

May 9, 2023

Speaker

Dr. Oliver Eikenberg, lead consultant QA/RA

The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 implemented a key requirement in Annex I, “General safety and performance requirements.” This requires that devices “shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose.” The definition of the eight criteria for an intended purpose is further defined in Annex I, Clause 20.4.1c.

This webinar will help you get a deeper understanding of the new IVDR requirement and learn how to avoid these pitfalls. The presenter will also discuss the comparison to the old IVD Directive and will share practical examples of case scenarios during CE marking submissions.

About the presenter

Dr. Oliver Eikenberg, lead consultant QA/RA

Dr. Oliver Eikenberg has over 23 years of medical device regulatory experience combined with more than 15 years of technical hands-on experience in IVD device development, manufacturing, and product management. Eikenberg’s background as a chemist with a Ph.D. in analytical chemistry, combined with many years developing and producing immunoassays and genetic tests, informs his detailed level of expertise in in vitro diagnostic devices. Over the last years, he was handling projects for more than >200 Technical Documentations reviews (EU) for high-risk up to low-risk IVD, including but not limited to SARS-CoV-2, PSA, HIV, TORCH, Alzheimer’s Disease markers, autoimmune markers, cancer markers, companion diagnostics and more.

In his role as lead consultant QA/RA, he focuses on medical device regulations in the EU, AUS and the U.S. He has managed several 510(k) submissions, performed 513(g) requests and Q-Sub (Pre-Sub) meetings with the U.S. Food and Drug Administration (FDA). His competence further includes audits on quality management systems, where he went through numerous ISO 13485 Notified Body audits and 21 CFR part 820 FDA inspections. He also acts as an internal auditor for Emergo by UL customers selling in Europe.