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The new Regulation on in vitro diagnostics (IVDR) severely affects IVD manufacturers and diagnostic laboratories. For laboratories, IVDR Article 5.5 dictates a number of conditions under which they are allowed to use their in-house devices (IH-IVDs, often referred to as laboratory developed tests, LDTs). This webinar will give an understanding of how the IVD market in the EU is regulated and why the IVDR requires the attention from all diagnostic laboratories. It will also provide details on what laboratories need to do by when to comply with the IVDR requirements and how this can be done.
Isabel DOMBRINK Dept. of Hematology, University Hospital Schleswig-Holstein, Kiel, DE
Isabel Dombrink studied biology in Bonn, Germany. She did her PhD thesis at the institute for cellular and molecular botany in the ecophysiology of plants group. She was interested in the apoplastic barrier in the roots, especially in the role of a specific gene family in the biosynthesis of this barrier. After finishing her PhD she worked as a Postdoc at the institute for molecular physiology and biotechnology in the molecular biotechnology/biochemistry group. She developed methods to qualify and quantify different kinds of plant lipids by mass spectrometry.
Bart LUBBERS European Scientific foundation for Laboratory Hemato Oncology (ESLHO), Leiden, NL After receiving a PhD in Neuroscience at the Vrije Universiteit (VU) in Amsterdam, Bart Lubbers worked as project manager at Sylics, a preclinical contract research organization. In 2017 he joined the department of Immunology at Leiden University Medical Center (LUMC), where he provided broad support to a number of international research consortia for innovation of diagnostics (i.e. EuroClonality, EuroFlow, ESLHO). Since 2021 he is only affiliated with ESLHO and its consortia. One of his main tasks is to help diagnostic laboratories prepare for the new European in vitro diagnostics Regulation (IVDR).
European Federation of Clinical Chemistry and Laboratory Medicine
Egmontstraat 11, Brussels Belgium
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