Double Session Event in the framework of the Codex4SMEs project

Friday, November 9, 2018
10.00 - 16.45
Verband Region Stuttgart
Kronenstrasse 25, 70174 Stuttgart, Germany

Introduction to the German healthcare system & market and the challenge of the new In-vitro Diagnostic Regulation IVDR


  • 10:00 -11:00 Introduction to the German healthcare system and market, Dr. med. Heidrun Sturm, Universitätsklinikum Tübingen
  • 11:00 – 12:30 IVDR part I – overview, classification and conformity assessment procedure, Dr. Andreas Stange, TÜV SÜD
  • 12:30 – 13:30 Lunch
  • 13:30 – 15:00 IVDR part II – most important modifications, technical documentation, clinical data, market surveillance and quality management, post market surveillance and current status of the designation of notified bodies, Dr. Andreas Stange, TÜV SÜD
  • 15:00 – 15:30 Q & A
  • 15:30 – 15:45 Coffee break
  • 15:45 – 16:45 Networking / Matchmaking

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