Performance Evaluation of In-Vitro-Diagnostic Devices (IVDs)

Sascha Wettmarshausen was involved in the entire legislative process of the IVDR and in constant contact with the EU Parliament, the Council and the Commission. At the VDGH, Mr. Wettmarshausen is responsible for the entire area of regulatory affairs (7 committees and working groups) and is heavily involved with the European association Medtech Europe (MTE). At MTE he holds the position of the Vice-Chair of the Regulatory Affairs Committee and is involved in 5 further working groups. Furthermore, he was involved in various guidance documents and is in close contact with the German Notified Bodies and other stakeholders.

Stefanie Giesener has continuously worked for various companies in the medical device industry in the field of quality management and regulatory affairs since 1995. Since 2009, she is Head of Quality Management & Regulatory Affairs at the German IVD manufacturer DiaSys Diagnostic Systems GmbH.

Beside her responsibilities in these companies, she was already engaged since 1997 in various committees in the German association of IVD manufacturers (VDGH), and in the European association (MedTech Europe) as well. In 2017 she became Member of the board at VDGH. She has already accompanied IVD manufacturers in their migration from the German Arzneimittelgesetz (AMG) to the European In vitro Diagnostic Directive (98/79/EC) and now she is responsible for the implementation of the IVDR at DiaSys.