Contribution to European Commission Call for Targeted Evaluation of the EU Regulation on In Vitro Diagnostics

JANE-2 NoE on Omics, led by Sciensano, contributed the European Commission’s public consultation about regulations on medical devices (MDR) and in vitro diagnostics (IVDR), conducted in March 2015, and submitted a statement for the evaluation of the EU Regulation on In Vitro Diagnostics (IVDR, EU 2017/746). This joint statement, written by omics experts active in the cancer domain, highlights six key issues with the regulation and provides recommendations.