eIFU since July 2025: permitted for all devices intended for professional users

The question of whether a medical device must be accompanied by instructions for use on paper has had a different answer since July 16, 2025 than in the three and a half years before. On that day, Implementing Regulation (EU) 2025/1234 entered into force, published in the Official Journal on June 26, 2025. It amends Implementing Regulation (EU) 2021/2226, which sets out the conditions under which manufacturers may provide the information required in the instructions for use under MDR Annex I Section 23.4 in electronic form instead of on paper. The core of the amendment fits in a single paragraph; its consequences reach as far as the UDI database.

Three device groups before, one criterion now

The original version of Art. 3(1) allowed an eIFU instead of paper for exactly three groups: (a) implantable and active implantable devices and their accessories, (b) fixed installed devices and their accessories, (c) devices fitted with a built-in system visually displaying the instructions for use. Added to this was the condition in paragraph 2 that the devices were intended exclusively for professional users and that use by other persons was not reasonably foreseeable.

The new Art. 3(1) reads: "Manufacturers may provide instructions for use in electronic form instead of in paper form where those instructions relate to devices referred to in Article 1(4) of Regulation (EU) 2017/745 intended for use by professional users." Art. 1(4) MDR groups medical devices, their accessories and the products listed in Annex XVI under the term "devices." The device list has disappeared, and with it the former Art. 1(3), which had excluded Annex XVI products from the scope.

Annex XVI products therefore also fall within the scope in principle. However, providing an eIFU instead of paper still requires that the device is intended for use by professional users within the meaning of Article 2(2) of the eIFU Regulation. Purely occupational use outside the framework of a professional healthcare activity does not automatically meet this requirement.

Lay persons continue to receive paper

Since the amendment, the line between professional users and lay persons is the only line the legal text still draws, and it draws it more sharply than before. Art. 3(2) in its new version: "Where it is reasonably foreseeable that a device intended for use by professional users is also used by lay persons, manufacturers shall provide the instructions for use intended for lay persons in paper form." The old version had excluded the eIFU altogether in that case; the new one requires a paper version for lay persons and permits the eIFU for professional users. Who counts as a professional user is defined in Art. 2(2): persons using the device "in the course of their work in the framework of a professional healthcare activity."

Two rules from the MDR itself complete the picture. Under Annex I Section 23.1(d), instructions for use are not required, by way of exception, for class I and class IIa devices "if such devices can be used safely without any such instructions." And for software, Art. 3(3) of the eIFU Regulation remains unchanged: the instructions for use may be provided "by means of the software itself."

What remains in place: the risk assessment and the conditions

The extension of scope leaves the core requirements on the manufacturer in place: Art. 4 continues to require a documented risk assessment with eleven minimum elements: the knowledge and experience of the target user groups, the characteristics of the environment, the users' familiarity with the hardware and software needed, access to electronic means "at the time of use," protection of the electronic data against unauthorized changes, safeguards in the event of hardware or software failure, "foreseeable medical emergency situations requiring the provision of information in paper form," the effects of a website or internet outage, the delivery time for a paper copy, display on different devices, and version management. The assessment "shall be updated in view of the experience gained in the post-marketing phase" (Art. 4(2)).

The fundamental requirements for the risk assessment and for providing electronic instructions for use remain in place; individual provisions of Article 5 have been amended. The risk assessment must show that the level of safety is maintained or improved; the eIFU is provided in all Member States where the device is made available; the manufacturer has a system in place to provide the paper version at no additional cost, "at the latest within 7 calendar days of receiving a request from the user" or at the time of delivery if so requested when ordering; information on emergency situations is given on the device or a leaflet; the design and functioning of the eIFU are verified and validated; revisions necessary for safety reasons are communicated to each user. For devices with a defined expiry date, the eIFU remains available for ten years after the last device has been placed on the market and at least two years after the expiry of the last device produced; for devices without a defined expiry date and for implants, 15 years. The website provides the instructions in the official language determined by the Member State. Point 13 has been reworded: all issued electronic versions are available on the website during these periods or, as regards obsolete versions, are made available upon request. In addition, the words "to the user or patient" have been deleted from point 11, and point 12 has been deleted (see below).

Art. 6 continues to require a clear indication that the instructions for use are supplied in electronic form, as a rule on the packaging of each unit or, where applicable, on the sales packaging, for fixed installed devices also on the device itself, together with information on how to access them: any information needed to view the instructions, the Basic UDI-DI and/or the UDI-DI, the manufacturer's contact details and the way to obtain the paper copy free of charge. The eIFU is available entirely as text, "with at least the same information as the instructions for use in paper form" (Art. 6(5)).

What has been deleted and what has been added

Five deletions and one new obligation change the procedural side. Art. 8 has been deleted; under it, compliance with Art. 4 to 7 was reviewed "where applicable" by a notified body in the conformity assessment procedure under Art. 52 MDR. The eIFU Regulation therefore no longer contains its own verification provision. However, compliance with the relevant requirements of Articles 4 to 7 must still be taken into account in the applicable conformity assessment procedures under the MDR. This includes in particular the risk assessment, the conditions for electronic provision, and the labeling and website requirements. Art. 6(4) has been deleted; it had excluded the part of the instructions intended for the patient from the electronic form in the case of implants. Also deleted are Art. 5(12) (notifying users after a download) and Art. 9(2) (website requirements for an eIFU offered in addition to a complete paper version). Finally, Art. 7(2)(f) has been deleted; under it, the website had to carry all previous versions of the electronic instructions for use with their date of publication, an obligation that now sits in point 13 of Art. 5 as amended. What remains is Art. 9(1): an eIFU provided in addition "shall be consistent with the content of the instructions for use in paper form."

New is Art. 7(3): at the latest from the date on which registration of devices in the UDI database becomes mandatory under Art. 123(3)(d) or (e) MDR, the manufacturer provides the internet address of the eIFU to the UDI database "in accordance with Part B, point 22, of Annex VI." In the MDR, that data element is called "URL for additional information, such as electronic instructions for use (optional)." For devices with an eIFU instead of paper, the Implementing Regulation turns the optional field into an obligation, and Art. 7(2)(e) continues to require that exactly this address remains unchanged and directly accessible throughout the archiving periods.

What the MDR itself says

Anyone opening the MDR still finds the old legal basis in Annex I Section 23.1(f): instructions for use may be provided in non-paper format "to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation." Regulation (EU) No 207/2012 was repealed by Art. 10 of Regulation (EU) 2021/2226 and continued to apply only to devices under Art. 120(3) MDR, until May 26, 2024. The same Art. 10 provides that references to the old Regulation are to be construed as references to the new one. Anyone quoting the MDR verbatim is therefore quoting a repealed regulation, and still means the right one.

The language question is governed by Art. 10(11) MDR regardless of the medium: the information under Annex I Section 23 accompanies the device in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. An eIFU reduces the printing and distribution effort; the language obligations remain, and Art. 5(11) of the eIFU Regulation repeats them for the website.

The eIFU Regulation does not apply to in vitro diagnostics. The IVDR settles the question itself, in Annex I Section 20.1(f): where the device is intended for professional use only, the instructions for use may be provided in non-paper format, "except when the device is intended for near-patient testing."

What follows for practice

For manufacturers who have had to print their instructions for use because their device fell into none of the three former groups, the switch has been open since July 16, 2025. The decision has six checkpoints, all of which come from the legal text: the intended purpose must name professional users and answer the question of whether use by lay persons is foreseeable; the risk assessment under Art. 4 must be in the technical documentation with all eleven elements and be kept current with market experience; the paper process must meet the seven-day deadline of Art. 5(3) free of charge; the labeling under Art. 6 must carry the eIFU notice, the UDI-DI and the ordering route for paper; the website must meet the requirements of Art. 7(2), including a stable address over ten or 15 years; and that address belongs in the UDI database as soon as registration becomes mandatory.

Entourage reviews label and instructions for use against MDR Annex I Section 23 and the eIFU Regulation as currently in force, from the risk assessment under Art. 4 to the labeling under Art. 6, in Labeling & IFU, and keeps the entry of the eIFU address in the UDI database consistent with the rest of the registration in Technical Documentation & UDI.