The use of state-of-the-art standards in the absence of harmonised standards under the IVD and Medical Devices Regulations (IVDR/MDR)

Only two months away until the Date of Application of the MD Regulation and two years for the IVD Regulation, there are no harmonised standards, let alone the Standardisation Request, a prerequisite for harmonisation. Industry remains in limbo as to which standards should be deemed appropriate to support the conformity to the respective legislations. The present document aims at exploring alternative solutions for manufacturers to consider in the absence of harmonised standards under the IVD and MD Regulations.