New EU regulation on e-IFU: what changes for medical devices?
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
On 25 June 2025, the European Commission published a new regulation that allows all medical devices used by healthcare professionals in the EU to be accompanied by instructions for use (IFU) in electronic format.
This update expands the use of e-IFU beyond the previous limitations, while maintaining the option for professionals to request a paper version if needed.
What are the benefits for manufacturers and healthcare systems?
The goal is to support the digital transition of EU healthcare systems. By switching to digital formats, manufacturers can reduce printing costs and environmental impact while making information easier to update and access.
The regulation also simplifies compliance processes and reduces the administrative burden for manufacturers, aligning with the EU’s broader strategy to boost innovation and competitiveness in the medical device sector.
Who is covered by the new regulation?
The measure concerns all medical devices used by healthcare professionals across the EU.
What are the next steps?
The Commission also announced two upcoming initiatives:
- the creation of an expert panel to advise on devices designed for small patient populations, such as children or those with rare diseases
- a full evaluation of the medical device and in vitro diagnostic regulations, aimed at reducing unnecessary burdens and improving efficiency. The conclusions will be presented in December 2025 during a conference in Brussels
In summary
- e-IFU are now allowed for all medical devices used by professionals in the EU
- paper versions must still be available on request
- the change supports sustainability, cost-efficiency, and digitalisation
- broader reforms of MDR and IVDR are under evaluation
Want to better understand how to adapt your documentation to the e-IFU format? Get in touch with us.
