Changes in the Management of Electronic IFUs

The Implementing Regulation (EU) 2025/1234

Instructions for use in electronic form can be provided as an alternative to paper format. Specifically, Annex I, Chapter III, point 23.1f) of Regulation (EU) 2017/745 states the following:

Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in subsequent implementing rules adopted pursuant to this Regulation.

Implementing Regulation (EU) 2021/2226 replaced, in December 2021, Regulation (EU) No 207/2012 cited as the starting point for regulating the provision of instructions for use in electronic form in the field of medical devices.

Finally, on June 25, 2025, Implementing Regulation (EU) 2025/1234, published in the Official Journal of the European Union, introduced some changes to Implementing Regulation (EU) 2021/2226.

The updates introduced by Implementing Regulation (EU) 2025/1234 have a dual purpose: to make certain information more accessible by avoiding overlaps with the MDR and to extend the scope of application.

In which Cases Can Instructions for Use be Provided in Electronic Form?

With Implementing Regulation (EU) 2025/1234, the types of devices to which electronic instructions for use can be applied have increased.

The previous Implementing Regulation (EU) 2021/2226, Article 3, limited its application only to certain medical devices and related accessories:

1) Manufacturers may provide instructions for use in electronic form instead of in paper form if such instructions concern one of the following devices:

• a) implantable medical devices and active implantable medical devices and their accessories, governed by Regulation (EU) 2017/745;
• b) fixed installed medical devices and their accessories, governed by Regulation (EU) 2017/745;
• c) medical devices and their accessories, governed by Regulation (EU) 2017/745 and fitted with a built-in system for displaying instructions for use.

2) Manufacturers may provide, for the devices listed in paragraph 1, instructions for use in electronic form instead of in paper form under the following conditions:

• a) the devices and accessories are intended for exclusive use by professional users; and
• b) use by other persons is not reasonably foreseeable.

3) For software governed by Regulation (EU) 2017/745, manufacturers may provide instructions for use in electronic form through the software itself instead of in paper form.

Implementing Regulation (EU) 2025/1234 amends Article 3 with the following wording:

1) Manufacturers may provide instructions for use in electronic form instead of in paper form if such instructions concern devices, referred to in Article 1(4) of Regulation (EU) 2017/745, intended for professional users.

2) Where it is reasonably foreseeable that a device intended for professional users will also be used by lay users, manufacturers shall provide instructions for use intended for lay users in paper form.

3) For software governed by Regulation (EU) 2017/745, manufacturers may provide instructions for use in electronic form through the software itself instead of in paper form.

The amendment of Article 3 leads to the following final considerations:

• All devices intended for use by professional operators can be accompanied by electronic instructions for use;
• With the update, in case of reasonably foreseeable use by professional operators and lay users, it is now possible to provide the electronic version to the professional operator and the paper version to the lay user;
• The devices subject to Annex XVI of the MDR are now included in the scope of application of Implementing Regulation (EU) 2025/1234.

What are the New Requirements to be Met for Providing Instructions for Use in Electronic Format?

In addition to the scope of application, some of the requirements to be met for providing instructions for use in electronic form have been revised.

Among the points subject to change, it is possible to identify:

• Removed the need to establish effective procedures and systems to notify users who have downloaded instructions for use from the website, in case of updates of various nature;
• The website no longer needs to make all previous versions of the instructions for use available. However, it remains necessary to provide obsolete versions upon request and to retain instructions for the following periods:
  • If the device has an expiry date: for 10 years from the date of placing on the market of the last device and for at least 2 years from the expiry date of the last device produced.
  • If the device does not have an expiry date: for 15 years from the date of placing on the market of the last device.
• Added the need to indicate in Eudamed the internet address where the instructions for use can be accessed.

What to Do if Electronic IFUs are Provided in Addition to Paper Ones?

This point is governed by Article 9 of Implementing Regulation (EU) 2021/2226 as amended by Implementing Regulation (EU) 2025/1234.

For manufacturers providing instructions for use in electronic form in addition to the paper format, only the need to keep the electronic version consistent with the paper support remains applicable.

Conclusions

It can be concluded that, with the amendment of Implementing Regulation (EU) 2021/2226, through the entry into force of Implementing Regulation (EU) 2025/1234, the scope of application has been widely extended.

Moreover, the reduction of burdens on a manufacturer of devices for which e-IFUs are considered applicable does not exclude the need to conduct careful risk management that may arise from the use of electronic instructions for use.