The use of predictive biomarkers in the diagnosis and prediction of the efficacy of targeted therapies for the individualized management of patients is generally based on the use of in vitro medical diagnosis devices that are now covered by the guidelines 90/385/EEC, 93/42/EEC and 98/42/EEC. On 25 May 2017, the European Parliament and Council Regulations 2017/745 and 2017/746 of 5 April 2017, related to medical devices and in vitro medical diagnosis devices, respectively, were published, disrupting years of practices based on European directives. They tend to bring the in vitro diagnosis in Europe closer to the American regulation in order to improve the use of safety diagnosis tests, while the United States have been changing their practices in the face of biomedical, technological and digital evolutions. We will describe the different regulations of diagnostic tests and discuss their applications in the field of oncology.
Keywords: in vitro medical diagnosis devices; oncogenetic diagnosis.