Webinar | Certification | IVDR
In our free, four-part IVDR webinar series, we cover 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.
Please note that the webinar has now finished. You can find the recordings of the webinar below.
