Joint statement supporting the expansion of the use of Electronic Instructions For Use (eIFU)
Medical Device Regulation (MDR) requires manufacturers to provide detailed instructions for use (IFU) to guide proper and safe use of medical devices and products. With the rapid evolution of technology and practices, eIFU Regulation no longer reflects the generally acknowledged state of the art and falls short of the needed legislation for a digital era.
EuromContact, together with 11 organizations therefore called on the Medical Device Coordination Group (MDCG) to consider as a priority the revision of the eIFU Regulation, with a view to expand the scope for specific product categories.
