Electronic instructions for use (eIFU) under Regulation (EU) 2021/2226: an implementation FAQ

9 Jul

Electronic instructions for use (eIFU) means providing a device's instructions for use on a website or a built-in screen instead of on paper. In the EU, it is governed by Commission Implementing Regulation (EU) 2021/2226, which sits under the Medical Device Regulation (Regulation (EU) 2017/745, or MDR) [Reg (EU) 2021/2226]. Since an amendment that entered into force on 16 July 2025, most medical devices intended for professional users may now use electronic instructions in place of paper — a much wider scope than the original rules allowed [Reg (EU) 2025/1234].

I assessed technical documentation for years at a notified body — an independent organisation that certifies devices. eIFU is one of those areas that looks like a simple cost saving and turns out to have a precise set of conditions attached. This post sets out what the rules require and how to make the switch properly.

What is eIFU, and what regulation governs it?

The instructions for use are the information a manufacturer must supply with a device so that it can be used safely. Traditionally that meant a paper leaflet in the box. eIFU lets you provide that information electronically instead — typically as a document on the manufacturer's website, or on a screen built into the device.

The governing text is Commission Implementing Regulation (EU) 2021/2226, adopted on 14 December 2021 and applicable from 4 January 2022 [Reg (EU) 2021/2226]. It is an implementing regulation, meaning it sets out the detailed rules for a specific part of the MDR — in this case, when and how electronic instructions may replace paper ones. It does not stand alone; it operates under the MDR.

Which devices can use electronic instructions for use now?

This is where the rules changed materially, so the date matters.

Originally (from 2022), electronic instructions could replace paper only for a narrow set of devices under Article 3 of Regulation (EU) 2021/2226: implantable and active implantable devices, fixed installed devices, and devices fitted with a built-in system that visually displays the instructions — plus their accessories. Even then, only where the device was intended for exclusive use by professional users and use by others was not reasonably foreseeable [Reg (EU) 2021/2226, Art. 3].

Since 16 July 2025, Commission Implementing Regulation (EU) 2025/1234 (adopted 25 June 2025) has extended that scope considerably. Electronic instructions may now be provided for any medical devices and their accessories that are intended for professional users, including the non-medical products listed in Annex XVI of the MDR [Reg (EU) 2025/1234, Art. 3(1)]. The amendment also brings the European database on medical devices (EUDAMED) into the management of electronic instructions.

One condition survived the expansion: the regime is for professional-use devices. Where it is reasonably foreseeable that a device intended for professional users is also used by a lay person — a patient, say — the instructions for that lay user must still be provided on paper [Reg (EU) 2025/1234, Art. 3(2)].

What conditions must a manufacturer meet?

eIFU is permission with strings attached, not a free pass. The core conditions in Regulation (EU) 2021/2226 are:

A documented risk assessment. You must assess and document the risks of providing instructions electronically rather than on paper — covering the users, their environment, and their access to the electronic version [Reg (EU) 2021/2226, Art. 4]. This is the condition assessors scrutinise most, and the one that weak implementations skip.
Availability on a website, free of charge. The instructions must be available on the manufacturer's website, at no cost, and accessible when users need them, in the official EU language(s) of the Member States where the device is made available [Reg (EU) 2021/2226].
A paper copy within seven days. If a user asks for the instructions on paper, you must provide them at no additional cost within seven calendar days of the request, or less if the risk assessment highlights this would be necessary. [Reg (EU) 2021/2226, Art. 5(3)]. Your process has to be able to deliver that.
Clear labelling. The label must clearly indicate that the instructions are supplied electronically rather than on paper, and tell the user how to access them [Reg (EU) 2021/2226, Art. 6(1)]. Note that EN ISO 15223-1:2021+A1:2025 includes a harmonised symbol for electronic IFU.
Keeping it current and available. The electronic instructions must stay accessible and up to date for the expected life of the device, with the website meeting the regulation's content and availability requirements.

This isn’t an exhaustive checklist; just meant to highlight the main requirements.

How to make the switch

In practice, moving a device to eIFU looks like this:

Confirm eligibility. Check that your device is within the current professional-use scope, and that lay-person use is either not foreseeable or handled with paper for those users.
Build a compliant website. Or, select an eIFU hosting partner.
Document the risk assessment. Use Article 4 as a checklist.
Verify and validate the website. There are various aspects to Articles 5-7 that require verification and validation. This is where selecting an eIFU hosting partner can pay off.
Set up the paper-on-request process. Make sure you can actually deliver paper within seven calendar days, and that you have a written process to do so.
Update the label and technical documentation. Add the eIFU indicator symbol and how to access the instructions, and fold the whole thing into your technical file.
Notified body assessment. For devices that fall under a notified body certificate, some level of assessment will be required before making your eIFU solution live. The level of assessment varies depending on the device classification.

What are the most common errors or pitfalls in implementing eIFU?

Not informing your notified body of the change.

Implementation of eIFU is a substantial change. If your devices fall under a notified body certificate (i.e. are classified higher than Class I), you’ll need to inform them, and they’ll need to do some level of assessment.

A superficial risk assessment.

When I was a technical documentation assessor at a leading notified body, one of the most common issues that I would see with new eIFU implementations was a light-touch risk assessment. Make sure each of the points in Article 4 is considered thoroughly, applying them to your device and website.

The eIFU risk assessment does not connect to the device risk management file

It’s acceptable to document an eIFU risk assessment separately - and this can be beneficial when you have multiple devices using the same eIFU website. However, you need to make reference to it in the device’s risk management file, and consider the output of the eIFU risk assessment in the device risk management report.

Not providing a clear conclusion that the eIFU maintains or improves the level of safety compared to paper IFU Article 5(1) requires that:

the risk assessment referred to in Article 4 shall demonstrate that providing instructions for use in electronic form maintains or improves the level of safety obtained by providing the instructions for use in paper form;

Whilst it doesn’t say you need to write this in a statement, it makes your assessment a lot smoother if you provide it as a documented conclusion somewhere.

Your post-market procedures don’t define how information will be collected on the effectiveness of eIFU

Article 4(2) requires that:

The risk assessment for the provision of the instructions for use in electronic form shall be updated in view of the experience gained in the post-marketing phase.

To do that, you need to collect post-market data about the eIFU. Make sure you include this in PMS plans for the devices using eIFU.

The website doesn’t make it clear if an IFU has been revised for safety reasons. Article 5(8) requires that:

they shall have a system in place to clearly indicate when the instructions for use have been revised and to inform each user of the device thereof if the revision was necessary for safety reasons;

In practice this means that where the eIFU is displayed on the website, it should make clear the revision number of the document, and call out if the revision was necessary for safety reasons. This does not mean that you have to contact the user that downloaded the eIFU to notify them; Article 5(12) previously indicated this, but was withdrawn with the amendments under Commission Implementing Regulation (EU) 2025/1234.

Hosting the eIFU on your own website

This one is just opinion - but I don’t think it is worth setting your IT team to task on creating a section of your website to host eIFUs. This is usually a route prone to errors, that results in setbacks to the project, and increases the overall cost. There are eIFU hosting providers out there that have all of the verification and validation information for the website ready to hand over to you, and you can include it in your QMS and technical documentation. This is definitely the faster route, and I would argue usually cheaper when all resources and delays are factored in.

Frequently asked questions

Which regulation governs eIFU for medical devices in the EU?

Commission Implementing Regulation (EU) 2021/2226, which operates under the Medical Device Regulation (Regulation (EU) 2017/745). It was amended by Commission Implementing Regulation (EU) 2025/1234, in force from 16 July 2025, which broadened the range of devices that may use electronic instructions [Reg (EU) 2021/2226; Reg (EU) 2025/1234, Art. 3(1)].

Can any medical device use electronic instructions for use?

No. Since 16 July 2025 the scope covers most medical devices and accessories intended for professional users, but it remains a professional-use regime. Where a device may also be used by a lay person, that user's instructions must still be on paper [Reg (EU) 2025/1234].

Do I still have to provide paper instructions if I use eIFU?

Sometimes, yes. You must provide a paper copy free of charge within seven calendar days if a user requests it (or fewer days if the risk assessment finds this necessary), and you must provide paper for any lay users of a professional device [Reg (EU) 2021/2226, Art. 5(3); Reg (EU) 2025/1234].

Does going electronic change what my instructions for use must contain?

No. The content requirements in Annex I of the MDR apply regardless of medium [MDR Annex I, Ch. III, 23.4]. eIFU changes how you deliver the instructions, not what they must say.

eIFU looks like a printing decision and is really a compliance project — a risk assessment, a compliant website, a paper-on-request process, and updated labelling and technical documentation, all of which a notified body will audit. Brightbark Cranberry helps manufacturers put eIFU in place so it is compliant, accessible and audit-ready; you can see how on the eIFU service page. If you would rather get the underlying technical documentation or regulatory strategy right first, we would be glad to help with that too.

Joseph Langley