For medical devices, it is possible to provide instructions for use in electronic form. However, this was previously restricted to certain products by Regulation (EU) 207/2012.

New rules under Regulation (EU) 2017/745

With the current Medical Devices Regulation (EU) 2017/745, this option was retained in Annex I, Chapter III. More precise regulation was provided by Implementing Regulation (EU) 2021/2226, which stipulates that electronic instructions for use (eIFU) are only permitted for certain medical devices and their accessories.

Purpose and function of implementing regulations

Implementing regulations serve to flesh out the general requirements of a regulation - in this case (EU) 2017/745 - for specific areas of application or situations.

Survey among healthcare professionals on the acceptance of electronic instructions

From August to October 2024, a survey was conducted among healthcare professionals with the aim of determining the acceptance of electronic instructions. The evaluation showed that a majority of professionals clearly prefer electronic instructions for use to paper-based ones. The reason given was that digital provision contributes to faster and more efficient solutions in the healthcare sector.

Planned expansion of the scope of application

Based on these results, the scope of the Implementing Regulation (EU) 2021/2226 is to be extended to all medical devices, their accessories and devices without a medical purpose, provided they are covered by Regulation (EU) 2017/745 and are intended for professional use. This also includes devices that are covered by the transitional arrangements under Article 120 of the Regulation.

Exception for use by laypersons

Exception: If a product is intended for professional use but may also be used by laypersons - such as patients - the instructions for use for this user group must continue to be provided in paper form.

Entry into force of the new regulation

The new Implementing Regulation (EU) 2025/1234 on the extended use of electronic instructions for use comes into force on July 16, 2025. From this date, manufacturers of medical devices will be able to switch to fully electronic documentation for the products concerned.