Date & Time
Feb 28, 2024 9:00am CST
The In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 is not only affecting legal manufacturers (companies) but also clinical laboratories using in-house tests. Though not all requirements apply to clinical laboratories, they must maintain technical documentation and update their quality management system to comply with the IVDR and national laws. The amended and phased implementation of the IVDR has set the first deadline to some of these requirements for May 2024.
This webinar will help you get a deeper understanding of the new IVDR requirements for clinical laboratories or parties involved in the manufacture or use of in-house tests. The presenter will explain the required actions in the remaining time (sprint) and share practical examples of how to comply with the IVDR in the long term (marathon).
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.