Medical device CE marking

New Regulation about electronic user instructions of medical devices


A new Regulation (2021/2226/EU) about electronic instructions for use (eIFU) of medical devices has been published. This Regulation outlines the circumstances in which the user instructions can be presented in an electronic format instead of paper format.

According to this Regulation, instructions for use may be provided as eIFU for the following types of devices, covered by Regulation MDR (EU) 2017/745 and intended for professional use only (e.g. use by other persons is not reasonably foreseeable):

  • Implantable, and active implantable medical devices and associated accessories;
  • Fixed installed medical devices and associated accessories;
  • Medical devices and associated accessories with an integrated system for displaying instructions for use.

For software covered by MDR, manufacturers may provide eIFU directly via the software itself.

Requirements to be met by the manufacturer to provide eIfU are further described in the Regulation.

The document can be downloaded from our library

Source: EUR-Lex