More options for electronic instructions for use– important updates for manufacturers

Until now, the Implementing Regulation (EU) 2021/2226 stipulated that instructions for use of medical devices must generally be provided in paper form.

The provision of electronic instructions for use was only permitted in three exceptional cases and for professionally used medical devices and accessories only: (i) implantable and active implantable, and (ii) permanently installed medical devices and accessories, as well as (iii) medical devices and accessories that incorporate a system for displaying instructions for use.

On June 26, 2025, the new Implementing Regulation (EU) 2025/1234 was published in the Official Journal of the European Union. In particular, the same provides manufacturers with more flexibility on providing instructions for use electronically. The Implementing Regulation entered into force 20 days after its publication in the Official Journal, i.e. on July 16, 2025.

The main changes

The new Implementing Regulation (EU) 2025/1234 stipulates that electronic instructions for use are generally permitted for all medical devices and accessories, provided that they are intended for professional use. Therefore, if a product is intended to be used exclusively in the course of professional activities and as part of professional healthcare services (e.g. by a doctor), the provision of electronic instructions for use is sufficient. This option for so-called eIFUs also applies to products listed in Annex XVI MDR – i.e., products without a medical purpose (e.g., contact lenses, body shaping devices).

Professional users can then access electronic instructions for use on the Internet. In future, manufacturers will have to enter the corresponding Internet address in the European Database for Medical Devices (Eudamed).

If products are intended for use by both professional users and laypersons, the instructions for use must continue to be provided in paper form to laypersons.

In addition, the new Implementing Regulation (EU) 2025/1234 clarifies that compliance with the requirements of the same must be verified (solely) in the conformity assessment procedure. Notified bodies are to be involved “only” to the extent provided for in the Medical Devices Regulation (EU) 2017/745. No further verification of the requirements must be carried out by Notified Bodies.

It should finally be noted that under the old regulation, outdated versions of electronic instructions for use always had to be available on a manufacturer's website. Now, the same only have to be provided on request.

Practical information

• The new Implementing Regulation introduces simplifications for products intended for professional use. However, if the products are intended for use by both professional users and laypersons, manufacturers are still advised to provide instructions for use in paper form as they do not have influence over which particular user will actually operate the specific product.

• Even under the old regulation, manufacturers were required to carry out a risk assessment in the event of a provision of electronic instructions for use. This situation has not changed with the new Implementing Regulation (EU) 2025/1234.

• Finally, it should be noted that even under the new Implementing Regulation, manufacturers must provide instructions for use free of charge and in paper form within seven days of receiving a respective request. 

Meike Kapp-Schwoerer and Francesca Pisacane will be happy to answer any questions you may have.