UEMS Sections warn that the Regulation EU 2017/746 (the IVD directive) is a threat to both precision medicine and crisis management if the Article 5-§5 conditions (d)-(i) are not removed. Indeed, failure to do so will increase health care costs and jeopardize our ability to design precise “personalized” laboratory tests (necessary for precision medicine) and to adapt to shifting test needs (such as repurposing instruments or making in-house PCR tests for covid-19 testing).
Read the statement here.