Webinar | Recording| IVDR
Watch the webinar recording now! In this four-part webinar series on the IVDR, our expert Thomas Fritzsch explains key topics around the new regulatory requirements for in vitro diagnostics. Learn how to implement IVDR safely and how TÜV NORD can support you as a Notified Body in conformity assessment.
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The new European regulation on in vitro diagnostic medical devices (IVDR) replaces the previous In Vitro Diagnostic Directive (IVDD) and introduces new requirements for device classification, clinical evidence, and post-market surveillance. In addition, it expands the oversight of Notified Bodies, making regulatory compliance more critical than ever.
In this free webinar series, our expert Thomas Fritzsch will provide practical insights into the most important IVDR requirements. He will guide participants from the fundamentals of regulatory compliance to technical documentation, performance evaluation, and performance studies.
The series is designed to give in vitro diagnostic device manufacturers a clear understanding of the regulation and the tools needed to achieve IVDR compliance.
The webinar series is aimed at manufacturers of in vitro diagnostics as well as professionals and executives in the medical technology industry. It is particularly relevant for those responsible in Regulatory Affairs, Quality Management, and Clinical Affairs who are involved in implementing IVDR.
This webinar provides a structured introduction to the IVDR. Topics include scope, risk classification, manufacturer obligations, and conformity assessment routes involving a Notified Body.
This webinar covers the requirements for technical documentation and post-market surveillance in accordance with IVDR. Using typical weak points as examples, it explains how documents must be structured and PMS processes integrated.
The focus is on the requirements for performance evaluation according to IVDR, including scientific validity as well as analytical and clinical performance data.
This webinar addresses IVDR performance study requirements from planning to Notified Body assessment.