New regulation | eIFU

Electronic instructions for use (eIFU)

The first week of 2022 a new regulation came into force, EU 2021/2226! This Regulation on electronic instructions for use (eIFU) of medical devices can be downloaded on our Unitron Regulatory website. Unitron Regulatory included a qualification flowchart to help determining if an eIFU can be provided instead of a paper IFU. If you like more information on the eIFU contact us or visit our Unitron Regulatory website.