Electronic Instructions for use (eIFU) for certain medical devices intended for lay users
Posted on 23.09.2025
Recently, the electronic instructions for use (eIFU) regulation (EU Regulation 2021/2226) has been updated by EU Regulation 2025/1234, which expands the possibility of eIFU to all professional use devices. The medical technology industry welcomed this initiative as it marks a crucial moment in the digitalisation of healthcare information.
In this context, MedTech Europe, Eurom and EuromContact wish to highlight that ongoing digitalisation efforts in the MedTech sector should be pursued in Europe, e.g. the introduction of eIFU for another group of devices. Such a step has the power to contribute significantly to supporting the European Green Deal’s overarching goals of climate neutrality, sustainability, and resource efficiency.
We propose expanding the possibility of having electronic instructions for use (eIFU) for certain medical devices used by a lay user when the following applies:
- Professional guidance during initial use: Providing an explanation or training from a healthcare professional at the outset ensures that users understand how to use the device correctly from the beginning
- Recurrent use fostering familiarity: Repeated use of a device helps users become more comfortable and proficient through practice, leveraging the repetitive nature of their application.
MedTech Europe, Eurom and EuromContact hereby call on the Medical Devices Coordination group (MDCG) to establish a dedicated workstream under the MDCG New Technologies working group to address this further eIFU expansion.
Read the full paper below.