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eIFU for lay users: why we support opening it, safety first

Paper is still mandatory wherever lay use is foreseeable. Why the line sits there, why we support the industry proposal to move it, and the safety test it must pass.

Koen Stynen 8 min de lectura
eIFU Regulation · IVDR · MDR

Since 16 July 2025, manufacturers of every professional-use device under the MDR may provide electronic instructions for use instead of paper, subject to a risk assessment. Lay use was not included. MedTech Europe, eurom and Euromcontact have asked the Medical Device Coordination Group to look at changing that. We support their proposal, on the test the regulation already sets: the risk assessment must show that electronic instructions maintain or improve the level of safety obtained with paper.

The rule today

Manufacturers may provide instructions in electronic form for devices intended for use by professional users (Article 3(1)). Where it is reasonably foreseeable that such a device is also used by lay persons, the instructions intended for lay persons must be on paper (Article 3(2)). A lay person is an individual who does not have formal education in a relevant field of healthcare or medical discipline (MDR Article 2(38)).

Whether that duty falls on the whole device or only on the lay-person instructions is unsettled. Before the 2025 amendment, Article 3(2) set two conditions on the device: exclusive use by professional users, and use by other persons not reasonably foreseeable. Regulation (EU) 2025/1234 replaced them with a duty framed on the instructions intended for lay persons, which supports reading Article 3(2) as a duty about the instructions. Article 6(1) supports the other reading. The label must still say that the instructions are supplied in electronic form instead of in paper form, which reads awkwardly for a device shipping both. No endorsed MDCG guidance addresses the point.

One route already reaches lay users. On the text of Article 3(3), software covered by the MDR may deliver its instructions through the software itself, with no professional-user condition. The risk assessment and the conditions in Article 5, including paper on request, still apply. Whether Article 3(2) applies to professional-use software that lay persons also foreseeably use is not resolved by the text.

What industry has asked for

Before the current proposal, the point had been put to the MDCG and the Commission at least twice. In February 2024, twelve associations asked the MDCG to prioritise revising Regulation (EU) 2021/2226 in its 2024 work programme, to expand the scope for specific product categories. In March 2025, responding to the Commission consultation on the draft amendment, MedTech Europe wrote that further digitalisation initiatives need to be envisaged, “such as eIFU for lay users (particularly where the lay user is trained by a professional)”. The amendment as adopted did not include them.

The three associations published a joint position paper in September 2025. It proposes two qualifying criteria: professional guidance during initial use, and recurrent use that builds familiarity. Its annex applies them to thirty-eight categories across classes I to III, including contact lenses, urinary catheters, glucose monitors, ostomy products, CPAP devices and oxygen concentrators. The paper also proposes two safeguards: the user should always be able to request a paper copy, and the risk assessment under Article 4 would continue to apply.

The paper makes environmental, accessibility and administrative arguments. It argues that removing the paper instructions decreases waste and reduces packaging size. It also attributes reductions in ethylene oxide emissions during sterilisation, and in printing and transport emissions, to the change. It argues that digital delivery, through dynamic instructional content, can help users with visual or cognitive impairments.

The ask itself is procedural. The associations want the MDCG to set up a dedicated workstream under its New Technologies working group.

Why the line sits where it does

None of the three eIFU regulations, of 2012, 2021 and 2025, gives an express reason for keeping lay use on paper. In our reading, the history of the scheme gives some context. When electronic instructions were first allowed in 2012, they were limited to five device categories, each intended for exclusive use by professional users (Regulation (EU) No 207/2012, Article 3). The 2025 extension kept that focus. EU regulations open with recitals, numbered paragraphs that explain why the regulation was adopted. Those of Regulation (EU) 2025/1234 refer to a Commission survey showing “a clear preference, among healthcare professionals” for electronic instructions (recital 2).

The 2025 extension covered professional-use devices only, citing a clear preference among healthcare professionals.

The associations’ paper adds a different source. It cites a European Patients’ Forum survey from November 2024, in which 58% of respondents were open to receiving device instructions in digital form only.

What an expansion has to meet

In our reading, any expansion has to meet three conditions the framework already sets, and all three concern the patient’s safety.

  1. The risk assessment must demonstrate that electronic instructions maintain or improve the level of safety obtained with paper (Article 5, point (1)).
  2. Devices for lay persons must perform appropriately for their intended purpose, taking into account “the skills and the means available to lay persons” (MDR Annex I, Section 22.1). In our reading, that includes digital skills. In 2025, 95% of EU households had internet access at home, while 60% of people aged 16 to 74 had at least basic overall digital skills, according to Eurostat.
  3. The risk assessment must cover the impact of the website or the internet being temporarily unavailable, or of access to them in the healthcare institution. It must also cover the safety measures available to cope with it (Article 4(1)(h)). A person at home has no institutional connection to fall back on.

The proposal addresses each of these. Professional guidance at first use and recurrent use speak to the user’s skills. A paper copy stays available on request, although that can take up to 7 calendar days (Article 5, point (3)). At the moment of use, the safeguards remain the Article 4(1)(h) assessment and the emergency information required by Article 5, point (4). And because the Article 4 risk assessment continues to apply, in our reading each device would still have to pass the safety test.

Electronic instructions are allowed only where the risk assessment shows safety is maintained or improved.

What an expansion can build on

In our reading, most of the safety conditions an expansion would need already exist in Regulation (EU) 2021/2226, written mainly with professional users in mind. They already apply to software under Article 3(3), including software intended for lay users.

ConditionWhere it already sits
Paper copy on request at no additional cost, within the period set in the risk assessment and at the latest within 7 calendar days, or at delivery if requested at the time of orderArticle 5, point (3)
Assessment of the user’s access to the reasonably foreseeable electronic resources needed at the time of useArticle 4(1)(d)
Information on foreseeable medical emergencies on the device or a leaflet, and how to start a device fitted with a built-in system displaying the instructionsArticle 5, point (4)
Users informed where a revision was made for safety reasonsArticle 5, point (8)
Every issued electronic version and its date of publication kept available, obsolete versions on requestArticle 5, point (13)
Access information on the packaging or, if not practicable, on paper supplied with each deviceArticle 6(2)
A stable, directly accessible address for the whole retention periodArticle 7(2)(e)
The internet address supplied to the UDI database, no later than the date UDI database registration appliesArticle 7(3)

Two practical points would be worth settling in the workstream. One is an offline copy the user can keep. The other is a paper request route that a patient can use as easily as a hospital purchasing department.

The IVD track is separate, and it is moving

For in vitro diagnostics, the rule on non-paper instructions sits in the IVDR. Non-paper instructions are permitted when the device is intended for professional use only, except when it is intended for near-patient testing (Annex I, Section 20.1(f)).

The Commission’s simplification proposal of 16 December 2025, COM(2025) 1023 final, would delete that exception. The proposed point (f) reads: “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).” It adds no conditions. Near-patient tests are intended to be performed by a health professional (IVDR Article 2(6)). Self-tests, intended for lay persons, stay outside (IVDR Article 2(5)). The Parliament committee vote on the proposal is scheduled for 3 December 2026.

Our view

Nothing has changed yet. Where lay use of a professional-use device is reasonably foreseeable, the instructions intended for lay persons go on paper. For a mixed-use device, the reasoning on the unsettled Article 3(2) question belongs in the risk assessment.

We think the associations’ proposal is a sound basis for moving that line. Its criteria look at how the user learns and uses the device, and paper stays available to any user who asks. The risk assessment would still have to show, device by device, that safety is maintained or improved. Where that cannot be shown, paper should stay.

Two things are worth watching. One is the New Technologies working group’s work plan, if it is published. The other is procedure 2025/0404(COD), the legislative file for the Commission’s simplification proposal.

Sources

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About this post

Ydntfy runs electronic instructions for use for medical device and IVD manufacturers. We built it because we believe instructions for use should be digital, as long as patient safety comes first. The view in this post is ours, and it is conditional on the safety test in Article 5, point (1). The platform supports the website and version requirements of Articles 5 and 7 of Regulation (EU) 2021/2226 for devices under the MDR. For IVDs, it supports electronic instructions for professional-use devices other than near-patient tests, under Annex I, Section 20.1(f). The risk assessment and the labelling remain the manufacturer’s.

Originally published at https://ydntfy.com/en/blog/eifu-lay-users-industry-proposal/ on 24 September 2026. You are welcome to quote or reuse this, with a link back.