Electronic IFUs: when they can replace the paper format. Opportunities and Critical Issues

The Point

Digitization of information delivered with a medical device is an issue that is beginning to gain traction. Electronic instructions for use, (or e-IFUs), in the industrial context can reduce paper, logistics costs, packaging time, information update time, and more. However, placed in the regulatory context, they do not represent a true "free alternative to paper." The possibility of replacing paper instructions for use with an electronic format is allowed only within precise, documented and verifiable conditions.

The starting point remains Regulation (EU) 2017/745 (MDR), according to which the instructions for use are the information provided by the manufacturer to inform the user about the intended use of the device, its proper use, and precautions to be taken. The MDR also requires that each device be accompanied by the information necessary to identify it, identify its manufacturer, and ensure that it is used safely and in accordance with its intended performance. The medium, format, content, readability, and location of the information must be appropriate to the device, its intended use, and the knowledge, experience, education, or training of the intended users.

The MDR permits the provision of instructions in non-paper format, including electronic format, only to the extent and under the conditions set out in the implementing regulations. Today, the main reference for MDR medical devices is Implementing Regulation (EU) 2021/2226, which governs when instructions for use can be provided in electronic instead of paper form.

The definition of e-IFU is broad: the concept includes instructions displayed by the device, contained in a portable electronic medium provided by the manufacturer with the device, made available through software, or published on a website. This breadth should not, however, be confused with a blanket freedom of paper replacement. The regulation distinguishes between mere additional electronic availability and true replacement of paper IFUs.

One important limitation should be clarified and that is for devices without medical purposes. In fact, the aforementioned regulation does not apply to products without medical purpose listed in Annex XVI of the MDR.

According to Regulation (EU) 2021/2226, the manufacturer may provide electronic instructions in lieu of paper for specific categories: implantable and active implantable devices and their accessories; fixed installed medical devices and their accessories; and devices and accessories with an integrated system that displays instructions for use.

For these categories, paper replacement is allowed if the devices are intended for use by professional users only and if use by others is not reasonably foreseeable.

For software (SaMD), instructions may be provided electronically through the software itself instead of in paper format.

The most important point is the assessment of the risk that may result from their use; the manufacturer who intends to replace paper-based IFUs must prepare a documented assessment that considers at least:

1. the knowledge and experience of the intended users,
2. the environment of use,
3. the user's familiarity with hardware and software required to display the instructions,
4. access to electronic resources at the time of use,
5. the protection of content from tampering,
6. back-up mechanisms in case of failure, emergency situations in which paper-based information may be needed,
7. the temporary unavailability of the site or the Internet,
8. the time required to provide a hard copy upon request, and the management of different versions of instructions.
9. perimeter of applicability,
10. risk control,
11. document governance.

This assessment needs to be part of the post-market experience review process to make necessary updates.

Thus, substitution is only sustainable if the manufacturer demonstrates that the use of the electronic format maintains or improves the level of safety achievable with paper. Therefore, it is not enough to publish a PDF online. There must be evidence of verification and validation that electronic instructions work properly, information on the hardware and software requirements needed to consult them, a system for reporting revisions, and, when revision is necessary for safety reasons, a system for informing users.

An additional critical requirement concerns the availability of the paper format. Even when electronic IFUs replace paper ones, the manufacturer must have a system in place to provide the paper instructions free of charge to the user who requests them, within the period defined in the risk assessment and in any case no later than seven calendar days after the request, or at the time of delivery if requested at the time of ordering.

This requirement prevents e-IFU from being viewed as a purely commercial or "environmental" choice: the alternative availability of paper becomes part of the risk control.

The Opportunities

The opportunities are obvious. E-IFUs make it possible to make an up-to-date version of instructions accessible, to handle multiple languages more efficiently, and to reduce the dispersion of outdated versions. Indeed, Regulation 2021/2226 requires that instructions be available on the manufacturer's website in the official language of the Union established by the member state where the device is made available to the user or patient. For devices with a defined expiration date, except implantables, e-IFUs must remain available for ten years after the last placing on the market and at least two years after the end of the expiration date of the last device produced; for devices without an expiration date and implantables, the period is fifteen years.

The technical dimension of the website is not secondary. If instructions are made available via a site, the format must be commonly used and readable with freely available software; the site must be protected from unauthorized access and tampering with content, reduce downtime and display errors as muchas possible , comply with GDPR, maintain a stable and directly accessible address, and retain previous versions with relevant publication date.

Critical issues

The main critical issues are in three areas:

A frequent (and common!) mistake is to assume that the presence of a QR code or web page is enough to replace paper. In reality, the QR code may facilitate access, but it does not by itself demonstrate compliance. Technical documentation must document applicability rationale, risk assessment, solution validation, IT requirements, revision control, historical availability, content protection, and procedure for providing the hard copy.

Bottom line,

electronic IFUs are a real opportunity. But their adoption must also be treated as a decision from a regulatory and risk management perspective, not merely a logistical or commercial choice. The correct question is not "can we put IFUs online?" but "can we demonstrate that, for this device, these users and this context of use, the electronic format maintains or improves security over paper?" Only when the answer is documented, verified, and consistent with Regulation (EU) 2021/2226 can the eIFU truly replace the paper format.