Electronic instructions for use for medical devices (EU law)

EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226.

We have summarized the requirements for electronic instructions for use for you.

1. Requirements for the use of electronic instructions for use

According to Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met: