EU Regulation 2017/745 (MDR) establishes the general requirements for instructions for use (IFU). Whether they can also be provided in electronic form (eIFU) is regulated by Implementing Regulation (EU) 2021/2226. It was revised by Implementing Regulation (EU) 2025/1234. A consolidated version is also available now.
We have summarized the requirements for electronic instructions for use for you.
1. Requirements for the use of electronic instructions for use
According to Implementing Regulation (EU) 2025/1234, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met:
- The devices and accessories are intended for exclusive use by professional users.
- In contrast to the original version of Implementing Regulation (EU) 2021/2226, the device categories in Article 3 have been removed; this means that an eIfU is now possible for all product types.
- And: a risk analysis has been carried out that covers the following:
- Users’ experiences with the device and with eIFUs
- Context of use (is a computer available?)
- Impact of the IFU being inaccessible (e.g., the Internet is not available)
- The website’s compatibility in terms of displaying the eIFU on different devices
- Potential emergency situations
- Protection against falsification of the IFU and management of different versions, if applicable
- Time for the user to obtain a paper version
- And: the instructions for use (IFU) can be made available in paper form within seven days.
- And: the existence of an eIFU is indicated on the label.
- And: the eIFU is available on the manufacturer’s website.
- And: a “mini-instructions for use” is available for emergencies and installation (and also explains where to obtain a paper version).
2. eIFU for software even when used by laypersons
For software as defined by the MDR, the electronic form is also permitted even if the device is not used only by professionals. For medical software, an eIFU is allowed even when the device is used by lay persons. The electronic instructions for use must be provided through the software itself and not in paper form (Article 3 (3) of Implementing Regulation (EU) 2021/2226, no change by Implementing Regulation (EU) 2025/1234).
3. Special case: IVDs and devices without an intended medical purpose
Implementing Regulation (EU) 2021/2226 on electronic instructions for use does not apply to in vitro diagnostic medical devices (IVDs). For them, the IVDR governs when manufacturers may deviate from the paper form:
“When the device is intended for professional use only, instructions for use may be provided to the user in non-paper format (e.g. electronic), except when the device is intended for near-patient testing.”
IVDR (Regulation 2017/746) Annex I, Chapter III, 20.1.f
Implementing Regulation (EU) 2025/1234 now explicitly covers devices without a medical purpose in accordance with Annex XVI of the MDR.
4. Relevance of the regulation even without eIFU
Implementing Regulation (EU) 2021/2226 is not only relevant when manufacturers use a pure eIFU. Annex I, Article 23.1 of the MDR stipulates:
Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date […]
That means that all manufacturers must upload their IFU (or the relevant content) to their website. This is precisely where Article 9 of Regulation 2021/2226 comes in:
- In addition to the MDR, it requires manufacturers to upload the exact equivalent of the paper version of the instructions for use.
- That only applies to the instructions for use, not to the labels. The MDR does not require these to be published online, only their content, which is also covered by the instructions for use MDR.
- Here, too, Implementing Regulation (EU) 2025/1234 has made a further simplification: If the device already comes with a paper IFU, the manufacturer is not required to comply with the requirements of Article 7 on the website (although we still recommend doing so, as the IFU is part of your device).
5.1 Changes introduced by Regulation 2021/2226
Implementing Regulation 2021/2226 has replaced the previous EU regulation 207/2021, which was previously also valid under the MDR. However, Regulation 207/2021 remains valid for devices placed on the market or put into service during the transitional period according to Article 120 (3) of the MDR.
You can find out more about the MDR transition periods in our article on transition periods.
The most important changes introduced by the new Implementing Regulation 2021/2226 are:
a) Software
eIFUs can now be provided for software even if the software is used by lay persons.
b) Risk assessment
Two points have been added to the risk assessment according to Article 4:
(j) | assessment of the website’s compatibility displaying the electronic instructions for use with different devices which could be used to display those instructions;
(k) | management of different versions of the instructions for use, where applicable in accordance with Article 5 (8).
c) eIFU on the manufacturer’s website
The manufacturer’s obligation according to Article 5 (12) when providing an eIFU is also worth noting:
“effective systems and procedures shall be in place to ensure that device users having downloaded instructions for use from the website can be informed in case of updates or corrective actions with regards to those instructions for use.”
If an eIFU is provided, it must be available on the manufacturer’s website (Article 5 (11)).
(13) all issued historical electronic versions of the instructions for use shall be available on the website.
Note: Articles 5 (12) and 5 (13) were deleted or fundamentally revised by Implementing Regulation (EU) 2025/1234 (see Chapter 5.2 below).
d) eIFU on device labels
According to Article 6 (1), manufacturers must now clearly indicate in the labeling that the instructions for use for the device are supplied in electronic form instead of in paper form.
Symbol 5.4.3 from ISO 15223-1 or ISO 7000-1641 with the addition of “eIFU” and “Indicator” can be used to do this.
The eIFU indicator can be a manufacturer’s website URL or some other appropriate indication that the instructions for use are available in an electronic format.
The “mini instructions for use” explaining how to access the eIFU should now also contain the Basic UDI-DI or UDI-DI (Article 6 (3) (b)). Since the Basic UDI-DI is only suitable for identifying specific devices to a limited extent, we recommend using the UDI-DI, which is already part of the label in accordance with Article 23.2 (h) of Annex I of the MDR.
5.2 Changes introduced by Regulation 2025/1234
The Implementing Regulation (EU) 2025/1234 actually manages to process feedback from various stakeholders (manufacturers and users alike) and thereby achieve evidence-based deregulation, which makes it easier and more efficient to provide eIFUs and thus ensures better availability of information.
The most important changes brought about by the new Implementing Regulation (EU) 2025/1234:
a) Device categories
Probably the most important change: Article 3 no longer limits the use of an eIFU to certain devices (implantable, permanently installed, or system for displaying the IFU), but allows its use in general for all devices within the scope of the MDR for professional use – including devices in accordance with Annex XVI.
b) Downloading the eIFU
Until now, Article 5 (12) required the manufacturer to inform every user who downloaded the IFU of any changes. Since not every person who downloads the IFU is also a user of the device – and this requirement is covered by post-market surveillance anyway – this point has been removed.
c) Version history
Instructions for use are often revised for safety reasons. In such cases, the use of an outdated IFU may pose a risk. That is addressed by the amendment in Article 5 (13): Manufacturers are now only required to list withdrawn versions of the eIFU on their website and can make them available on request if necessary. If several versions are valid simultaneously, it must be possible to clearly assign them to a specific device.
d) EUDAMED and IFU
Article 7 is expanded to strengthen the link with EUDAMED and thus further improve the availability of information. Manufacturers must ensure that the website on which the IFU can be found is also stored in EUDAMED in exactly the same way:
At the latest at the date from which the registration of devices in the UDI database referred to in
Article 28 of Regulation (EU) 2017/745 applies in accordance with Article 123(3), point (d) or point (e), of
that Regulation, as applicable, the manufacturer shall provide the internet address referred to in paragraph (2),
point (e), of this Article to the UDI database in accordance with Part B, point 22, of Annex VI to Regulation
(EU) 2017/745.’;
e) Digital IFU in addition to paper
If manufacturers also provide a paper IFU, the website for providing the digital IFU does not have to comply with any special requirements. However, uploading the IFU remains mandatory (see also chapter 4).
6. Conclusion
The introduction of electronic instructions for use is a great relief for a lot of users and will also provide a lot of benefits for medical device manufacturers as well. Manufacturers who want to provide instructions for use in electronic form should study the requirements of Implementing Regulation 2021/2226 carefully and take into account the possible risks associated with using electronic instructions for use.
With Implementing Regulation (EU) 2025/1234, the EU is taking a major step toward digitalization and environmental protection. It will save an average of around 500 tons of paper per company per year. In addition, the regulation improves the availability of information and – hopefully – increases compliance by users.
Change history:
- 2025-09-08: Link to the consolidated version of Implementing Regulation (EU) 2025/1234 added
- 2025-08-11: Changes due to Implementing Regulation (EU) 2025/1234
- 2024-08-22: Chapter “Relevance of the regulation even without eIFU” added
- 2022-01-20: Changes due to Implementing Regulation (EU) 2021/2226; guidance on IVD added
Hi Christopher,
Thank you for the article.
However, I have another interpretation of article 9 of 2021/2226. Indeed, I rather understood the requirement as follows: the electronic instructions that are provided to complement the instructions for use in paper format, must be consistent with the content of the instructions for use in paper format.
Indeed, in the absence of a comma after the “addition to”, shouldn’t “complete” be considered a verb?
What’s your opinion about it?
Thank you in advance.
Dear Louison,
thank you for your question!
In my opinion, this “additional IfU” would then be considered a seperate eIfU falling completely under the full scope of the regulation, not only article 9. It would not be “consistent with the content of the instructions for use in paper form”, but rather with the format, as this electronic content is not written down on paper.
This matches all the translated versions (e.g. German, Spanish, French). Not sure if a comma would really change the meaning – if it was there after “addition” and before “to”, then I would completely agree with you.
Kind regards
Christopher