The new EU Regulation on in vitro diagnostic medical devices (IVDR) will come into full effect per May 26, 2022 and will have substantial consequences for diagnostic laboratories.

EHA has recently brought key stakeholders around the table to discuss bureaucratic obstacles in clinical research. Regulators, patient organizations, the European Commission and industry representatives were invited for a day-long discussion at EHA offices, building on an informal dialogue with the European Medicines Agency (EMA) that had been initiated by a group of prominent clinical researchers.