eIFUs Now Allowed for All Professional Use Devices

On June 27, the EU published Commission Implementing Regulation 2025/1234 ((Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025 amending Implementing Regulation (EU) 2021/2226 as regards the medical devices for which the instructions for use may be provided in electronic form) ), significantly expanding the scope of medical devices that can provide electronic Instructions for Use (eIFUs).

This change gives you new opportunities to digitize IFUs — but strict compliance requirements still apply.

Background

Previously, the electronic Instructions for Use (eIFUs) Regulation 2021/2226 only permitted eIFUs for the following types of medical devices:

• If they are for professional use and use by other persons is not foreseeable:
  • Implantable and active implantable devices,
  • Fixed installed medical devices and their accessories, and
  • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use.
• For software covered by the Regulation, the instructions may be provided in electronic format by means of the software itself.

The Update

Commission Implementing Regulation (EU) 2025/1234 (which amends eIFU Regulation) is available here.

Which devices are included in the new regulation?

The following types of products are now eligible for eIFUs:

• All medical devices and their accessories covered by EU MDR 2017/745, that are intended for professional users; this includes legacy devices under the MDR Art. 120 transitional provisions.
  • However, if the device may also be used by a lay person, such as patients, then the IFU intended for the lay person must be provided in paper form.
• Devices without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745, provided that they are intended for professional use.

Note that there is no obligation to utilize the eIFU allowance. The provision of eIFUs remains optional. This new amendment simply expands the eligibility criteria, should those manufacturers wish to supply eIFUs.

Expanded rules for electronic instructions for use (eIFUs) in summary

Effective: Published June 27th, entering into force 20 days later Amends: Commission Implementing Regulation (EU) 2025/1234 Purpose: To broaden the scope of devices eligible to provide IFUs in electronic form instead of paper.

The EU now allows all medical devices and their accessories intended for professional users to provide electronic Instructions for Use (eIFUs). This means the scope is no longer limited to devices like (active) implantables, fixed installed medical devices, and devices with a built-in system for visually displaying instructions. This change responds to industry demand and digital transformation trends.

What are the key changes?

1. Wider scope of eligibility

   • All devices and their accessories intended for professional use are now eligible
   • Applies even to devices without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745
   • Devices under transitional MDR provisions are included
   • If lay persons are likely users, a paper IFU is still required for them

2. Compliance requirements remain strict

   • A documented risk assessment is still mandatory
   • Manufacturers must ensure:
   • Secure and user-friendly access to eIFUs
   • Backup and emergency protocols
   • Website uptime and data protection (GDPR)
   • Paper IFUs must be available on request, within 7 days

3. Labeling and website requirements

   • Product labels must indicate eIFUs are provided
   • Website must host current IFU and historical versions must be at least made available on request
   • eIFUs must be accessible in official EU languages, as applicable
   • From the moment registration in EUDAMED becomes mandatory, internet access URLs must be registered

How your company can take advantage of the updated regulation

You can now:

• Replace printed IFUs for a much wider range of devices
• Digitize documentation workflows, reducing costs
• Improve update speed and support sustainability goals.

How the eIFU solution from myHealthbox can help

myHealthbox makes full eIFU compliance simple with multilingual support, full multimedia support, version tracking, security and formats readable with standard browsers.

Our platform offers:

• A GMP validated platform
• Formats support: we provide eIFUs in widely accepted formats that can be read with freely available software.
• Security: protection against hardware and software intrusions to safeguard your information.
• Multilingual support: clear indication of the languages in which the eIFUs are provided (over 45 language supported)
• Multi country support: as every country may have different regulations, we provide all the tools to support them all, all in one place
• Stable internet address: guaranteed stable and accessible internet address for your eIFUs, in compliance with regulatory requirements.
• Enhanced search: besides QR codes on the package we support most barcode types plus textual search via our search engine or API access
• Version control: access to all previous versions of your eIFUs and their publication dates.

• Document content security with digital signature: we make sure that what your users received is always the intended document

  Questions ? !!!! Contact us