The European in vitro diagnostic industry appreciates the outcome of the vote in the European Parliament's Committee for Environment, Public Health and Food Safety (ENVI) but takes note of the Committee's decision to provide a transition period of only three years. The change to the new classification and the implementation of clinical evidence will potentially require manufacturers to go back to gather data on new studies. EDMA, the European in vitro diagnostic industry association, believes that the optimal transition period for the new IVD regulation is five years as gathering scientific data takes longer than the proposed period.
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