eIFUs Now Permitted for All Professional Use Devices: European Commission Publishes Amending Regulation 2025/1234

On 26 June 2025, the Official Journal of the European Union published Commission Implementing Regulation (EU) 2025/1234. This Regulation amends Commission Implementing Regulation (EU) 2021/2226, which was first introduced in 2021 to govern the provision of electronic instructions for use (eIFUs) of medical devices on the Union market.

With this amendment, the European Commission significantly expands the types of medical devices that may be supplied with eIFUs. As of 16 July 2025, manufacturers are permitted to provide eIFUs for all medical devices intended for professional use, subject to specific conditions and regulatory requirements.

Background

Previously, the scope of Regulation (EU) 2021/2226 was limited to a few specific categories of professional-use devices:

• Implantable and active implantable medical devices

• Fixed installed medical devices and their accessories

• Devices with built-in visual display systems

• Software, where instructions are provided within the application itself

Devices used by laypersons were excluded from eligibility for eIFUs. This restrictive approach reflected caution regarding accessibility and safety but created practical limitations in professional environments where digital documentation is often preferred.

In August 2024, the European Commission launched a survey among professional users to assess the interest in expanding access to eIFUs. The results were decisive: 87% of respondents expressed a preference for eIFUs. This led to the publication of a draft amendment in February 2025, followed by a public consultation. The feedback received strongly supported the proposed changes.

Scope of the Amendment

Regulation (EU) 2025/1234 expands eligibility for eIFUs to the following:

• All medical devices and accessories covered under Regulation (EU) 2017/745 (MDR), if intended for professional use, including legacy devices covered under MDR Article 120.

• Devices without a medical purpose listed in Annex XVI of Regulation (EU) 2017/745, provided they are intended for professional users.

However, where a device is intended for both professional and layperson use, manufacturers must continue to supply paper instructions to ensure accessibility for non-professional users.

Importantly, use of eIFUs remains optional. Manufacturers may choose to offer instructions in paper form if preferred.

Key Requirements for eIFU Provision

Manufacturers opting to provide eIFUs must ensure compliance with several updated regulatory obligations:

• A documented risk assessment must be performed (Article 4)

• Paper versions of the IFU must be made available on request, free of charge, within seven calendar days(Article 5(3))

• Emergency information and startup instructions must be provided physically on the device or accompanying material (Article 5(4))

• National language requirements remain applicable (Article 5(11))

• Previous versions of the eIFU must remain available online (Article 5(13))

• Product labels must indicate that the IFU is supplied in electronic format (Article 6(1))

• Clear instructions must be provided for accessing the eIFU (Articles 6(2)-(3))

• Once the EUDAMED UDI/Device module becomes mandatory, the web address to access eIFUs must be included in the device registration (Article 7(3))

  
  

Effective Date

The regulation enters into force 20 days after publication in the OJEU, making the effective date 16 July 2025.

Conclusion

Regulation (EU) 2025/1234 reflects a practical and widely supported shift toward digital documentation for medical devices intended for professional use. The amendment enables manufacturers to align product information delivery with modern healthcare workflows while maintaining safeguards for users.

Manufacturers considering eIFUs should review the amended requirements in detail and assess their internal procedures to ensure full compliance.