eIFUs Now Allowed for All Professional Use Devices: EU Amending Regulation 2025/1234 Published

Table of Contents

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.

In August 2024 the Commission opened a survey to collect feedback from professional users, on allowing eIFUs for all professional use medical devices. 87% of respondents stated they would prefer using eIFUs, if available to them.

In February 2025 the Commission opened a public consultation on allowing eIFUs for all professional use medical devices and published the draft act. The public response was positive in favor of extending eIFUs to all professional use devices.

The Update

Commission Implementing Regulation (EU) 2025/1234 (which amends eIFU Regulation) is available: HERE

Which devices are included?

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.

Requirements

The devices must meet the requirements under the newly amended eIFU Regulation (EU) 2021/2226. Examples of the requirements include:

Perform a documented risk assessment (Art. 4);
Have a mechanism to provide paper IFUs upon request, at no cost to the user, and within 7 calendar days at the latest (Art. 5(3))
Provide, on the device or a leaflet, information on foreseeable medical emergency situations and, for devices fitted with a built-in system visually displaying the instructions for use, information on how to start the device (Art. 5(4))
National member state language requirements must still be met (Art. 5(11))
Keep historical versions of the eIFUs available on the website (Art. 5(13))
Manufacturers must clearly indicate on the label that the IFU is supplied in electronic form, instead of in paper form (Art. 6(1))
Manufacturers must also provide information on how the user can access the eIFU, and the minimum information required to provide (Art. 6(2)-(3))
Once the EUDAMED UDI/Devices module becomes mandatory, manufacturers must enter the web address where the eIFUs are accessible (Art. 7(3))

Timing

The amending regulation enters into force 20 days after its publication in the Official Journal of the European Union (OJEU). The OJEU publication occurred today; therefore, the effective date is: Wednesday, 16 July 2025