Impacts of European In Vitro Diagnostic Regulation (IVDR) - Professor of Oncology and Head of Pathology , Italian Academic Medical Center

A professor of oncology and department head of a national cancer organization in Italy shares his views in IVDR’s integration into Italian clinical practice. They perceives IVDR as an essential step towards ensuring thorough certifications of laboratories. The stakeholder predicts that Italy will likely be able to cope with IVDR restrictions via its 50 labs utilizing NGS. They also shared a positive development from IVDR - the central government’s distribution of funds to various regions based on the epidemiology of tumors. The stakeholder suggests that oncologists, pathologists, and pharmaceutical and biotech companies collaborate to expedite the certification process and facilitate the implementation of IVDR effectively. They also point out the increasing importance of commercial laboratories such as Foundation Medicine or Guardant Health in the future. Overall, IVDR implementation is viewed as largely positive and expected to bring simultaneous changes in processes such as centralization, automation, and digital pathology in the field of diagnostics.