The European In-Vitro Diagnostics Regulation

The European In-Vitro-Diagnostics Regulation

by Iweta Metzger & Marion Fehlker, novineon CRO GmbH, Tuebingen, Germany

• IVDR: introduction and new risk classification
• Performance evaluation: three pillars for clinical evidence
• Clinical performance studies: purpose and requirements
• Post-market surveillance: requirements and implementation

• As small and medium-sized enterprise find qualified experts and collaboration partners in 1:1 meetings
• As Research and Technology Organisation find new partners for technology transfer
• As product developer find partners to discuss new technology and innovative solutions
  • After registration, book virtual one-to-one meetings via this link.

The Biomarker Commercialization Guide and the IVDR Guide of the BiC project

by Valérie Daussin Laurent, Aalborg University Hospital, Denmark

Paweł Myszczyński, Wroclaw Technology Park, Wroclaw, Poland

• Introduction to the BIC GUIDE, a support tool for commercialisation of biomarkers, from discovery to industrial launch of IVD based biomarkers
• The IVDR regulatory guide addressed to researchers and SMEs