On 26 June 2025, the Official Journal of the EU published Commission Implementing Regulation (EU) 2025/1234. The Regulation amends Commission Implementing Regulation (EU) 2021/2226 published in 2021 about electronic instructions for use (eIFUs) of medical devices on the Union market.
Electronic IFUs use extended for all devices for professional use
The results of the recent public consultation on electronic IFUs for medical devices showed a preference, among healthcare professionals, for receiving instructions for use in electronic form than in paper. Consequently, the use of electronic IFUs is extended to all medical devices and their accessories, including legacy devices and devices without an intended medical purpose listed in Annex XVI. Manufacturers shall provide all issued electronic versions and their date of publication on the website (for the time specified in Article 5.9 and 5.10 of Regulation (EU) 2021/2226). In addition, they shall provide obsolete version upon request.
With the new updated Regulation, the following applies:
- Manufacturers may provide instructions for use in electronic form (instead of in paper form) where those devices’ instructions are intended for use by professional users (Article 3.1).
- When that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form (Article 3.2).
Once EUDAMED UDI registration becomes mandatory, manufacturers should provide the internet address under which the electronic instructions for use are accessible.
Importantly, manufacturers shall always carry out a risk assessment for the appropriateness of use of eIFUs.
Questions on compliance of medical devices? Contact our Team at mdlaw@obelis.net.
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