e-IFU for all medical devices intended for professional users – new Commission Implementing Regulation (EU) 2025/1234

On 26 June 2025, the European Commission published Commission Implementing Regulation (EU) 2025/1234 in the Official Journal of the European Union. This regulation significantly expands the possibility of using electronic instructions for use (e-IFU) for medical devices. Previous restrictions — allowing e-IFU mainly for stationary or active devices — have now been lifted. The new rules allow all manufacturers of devices intended solely for professional users to forgo paper-based instructions.

Regulatory background and scope of the new implementing act

A new approach to information provision – who can use e-IFU?

The regulation permits broader use of e-IFUs, provided that certain conditions specified in the amendment are met. This includes:

devices covered by Regulation (EU) 2017/745 (MDR), provided they are intended exclusively for professional users,
accessories to such devices,
non-medical products listed in Annex XVI to the MDR,
legacy devices placed on the market under Article 120 MDR.

Crucially, the use of e-IFUs is prohibited if there is any risk that the device may end up in the hands of lay users, even if that is not the intended purpose. Manufacturers must have documented justification and control systems to demonstrate this risk has been eliminated.

New technical and information requirements of e-IFU

Manufacturers must ensure that:

the latest and previous versions of the IFU are available in a secure, electronic format,
access is provided through a stable and accessible platform,
the e-IFU location (URL) is published in the UDI database in EUDAMED,
e-IFUs are made available in all required national languages depending on the Member State where the product is marketed.

The information must be protected against unauthorised alteration and comply with applicable data protection requirements.

Implementation and implications for manufacturers

The regulation enters into force on 16 July 2025. This means that manufacturers need to:

review and update their quality management system procedures,
adapt their technical documentation to reflect the new e-IFU conditions,
develop and test digital publishing platforms for IFUs,
ensure compliance with MDR Annex I Section 23 on information provided to users.

It is important to note that using e-IFU remains optional. Manufacturers may still choose to provide paper-based IFUs. However, if opting for the digital version, full compliance with the new regulation must be demonstrated.

Summary

This update is a clear signal of the EU’s commitment to digital transformation in the medical devices sector. The changes are expected to support both environmental sustainability and operational efficiency by reducing the need for printing and distributing physical documentation.