Heiner Scheiblauer

Head IVD Testing Laboratory at Paul-Ehrlich-Institut

Speaker

Head of the IVD testing laboratory at the Paul-Ehrlich-Institut (PEI-IVD). Establishment of the PEI-EU reference laboratory according to the IVD Regulation 2017/746. More than 30 years of experience in virology in the field of pathogenicity of influenza viruses, viral safety of plasma derivatives and blood products and evaluation and regulation of diagnostics. Thirty-four scientific publications. Since 2000 collaboration with notified bodies in the framework of IVDD 98/79/EC for batch testing, product evaluation and on-site audits. Part of the WHO Collaborating Center at the PEI for quality assurance of blood products and in-vitro diagnostics, developing biological standards. Member of the expert committee of the European Commission in the field of medical devices and in vitro diagnostics, in the MDCG working groups for standards and IVD as well as EU representative for IVD in the IMDRF.