Instructions for Use (IFU) are a key component of medical device labelling in the European Union, essential for product safety and efficacy.
It is precisely in the context of managing this documentation that, on June 26, 2025, Implementing Regulation (EU) 2025/1234, amending the previous Implementing Regulation (EU) 2021/2226, was published in the Official Journal. Thanks to this initiative of the European Commission, electronic instructions for use (eIFU) will be extended to all Medical Devices intended for professional use: a welcome change that promises to reduce the burden on manufacturers through the greater use of digital tools. The new provisions will enter into force on July 16, 2025.
Please note that the instructions for use (IFU), whether in paper or electronic format (eIFU), are needed to provide users with all the information they need to use the device safely and effectively.
What changes with Regulation (EU) 2025/1234?
All devices intended for professional use, by healthcare professionals, can now only be accompanied by instructions in electronic format (eIFU), without the need for a paper version. It is very important to emphasise ‘professional use’: traditional paper IFUs remain mandatory if the product is intended for the lay user.
Also relevant is the fact that Regulation 2025/1234 also applies to non-medically intended devices listed in Annex XVI of the MDR, provided they are intended for professional use.
Furthermore, devices subject to the transitional provisions of the MDR, known as Legacy Devices, are also included.
This change represents a major step forward for manufacturers, who will now be able to manage documentation in a more streamlined and flexible manner.
However, beware of the dual purpose of a medical device: if a professional device can reasonably also be used by a patient or end consumer (lay user), instructions addressed to the latter must be provided in paper form (Article 3, para. 2 of Regulation 2025/1234).
Further key changes
The main changes in addition to the previous ones are listed below. The main changes include:
- Elimination of download tracking
The manufacturer will no longer be obliged to monitor eIFU downloads from the website. - Obsolete versions available on request
Older versions of eIFUs no longer have to remain on the website, but must still be made available on request. - EIFU links on EUDAMED
When the registration of devices on EUDAMED becomes mandatory, eIFU access URLs will have to be registered in the UDI form, in order to ensure centralised and easy access to information. - Labelling
Labels on devices should indicate that the instructions for use are available in electronic format. - Clarification on the Verification of Notified Bodies (NB)
The Regulation repeals Article 8 of 2021/2226 concerning the verification of eIFUs by Notified Bodies. However, as explicitly stated in recital 7 of Regulation 2025/1234, compliance with the manufacturer’s information obligations is already included in the conformity assessment activities under MDR (EU) 2017/745. The separate obligation (with Article 8) was therefore redundant. Verification, therefore, remains an integral part of the MDR compliance process, eliminating a potential duplication of controls.
In conclusion, the innovation embraces efficiency and sustainability through digitisation and marks a significant advance for the medical device industry. For manufacturers, Regulation (EU) 2025/1234 translates into greater operational flexibility and potential cost reductions, while maintaining safety standards and accessibility to essential information.
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Discover the Thema Checklist, your essential tool for verifying the completeness and compliance of your electronic Instructions For Use (eIFU), in accordance with Implementing Regulation (EU) 2025/1234.
SOURCE:
https://eur-lex.europa.eu/eli/reg_impl/2025/1234/oj
07/17/2025
