Industry proposals to expand electronic instructions for use (eIFU) for certain medical devices used by lay users

In June 2025, the electronic instructions for use (eIFU) regulation (EU Regulation 2021/2226) has been updated, expanding the possibility of eIFU to all professional use devices.

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
• Recurrent use fostering familiarity

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 Joint paper : Electronic Instructions for use (eIFU) for certain medical devices intended for lay users