Electronic instructions for use (eIFU): the 2026 guide
Short answer: electronic instructions for use let a medical device manufacturer supply its IFU online instead of on paper. In the EU, Regulation (EU) 2021/2226 sets the rules, and since 16 July 2025 its amendment, Regulation (EU) 2025/1234, opens eIFU to all devices intended for professional use. You must still send a free paper copy within seven calendar days when asked, keep every published version online for the retention period, and register your eIFU web address in EUDAMED.
The regulatory sections cite the regulation and article they come from.
What changed in 2025?
Article 3 of Regulation (EU) 2021/2226 used to list the specific device categories allowed to ship electronic instructions. Commission Implementing Regulation (EU) 2025/1234 entered into force on 16 July 2025 and removed that list. Electronic instructions are now available for:
- medical devices and accessories intended for professional use under Regulation (EU) 2017/745,
- legacy devices relying on the Article 120 transitional provisions, and
- products without a medical purpose listed in Annex XVI.
The hard part of the job moved from "may we do this at all" to "can we prove we did it properly for every SKU we sell".
What did not change: paper on request
A device intended for professional use that can reasonably be expected to be used by a lay person, for example a patient at home, still needs paper instructions in the box. Separately, Article 5(3) of Regulation (EU) 2021/2226 requires you to supply a paper copy free of charge within seven calendar days of a request. Widening eligibility widened the number of SKUs that obligation attaches to.
Version history is still your evidence
Regulation (EU) 2025/1234 deleted Article 5 point (12), the duty to notify users who downloaded an instruction about every later update. It did not remove the evidence burden. Article 5 point (13), as replaced, still requires every issued electronic version and its publication date to be on the website for the whole retention period, although obsolete versions may instead be made available on request.
Your eIFU address becomes a EUDAMED attribute
Article 7(3), added by the amendment, requires you to supply the eIFU internet address to the UDI database under Annex VI Part B point 22 of Regulation (EU) 2017/745, at the latest from the date device registration in that database applies. A change to that address is now a regulatory change, not a website tidy up.
What about the United States?
Section 502(f) of the FD&C Act, as amended in 2012, allows labeling for prescription devices intended for use in health care facilities or by health care professionals to be made available electronically, provided users can request a paper copy and receive it promptly at no additional cost. Devices used by patients at home generally still need paper labeling.
What eIFU software has to do
- Host controlled documents on a site that is treated as regulated infrastructure, not marketing.
- Keep every version with its publication date for the retention period.
- Handle paper requests within seven calendar days, with a record of each one.
- Serve the right language and region for each market you sell in.
- Come with validation evidence your quality team can file.
eIFU providers compared
(Matrix eIFU is made by the publisher of this guide.)
Matrix eIFU (formerly Dokspot)Medical device and IVD manufacturers of any size, from a few product lines to high SKU portfolios.Italy focused option
RealBit eIFUManufacturers selling mainly in Italy.Hosting only option
SmartEIFUTeams that only need document hosting.| # | Tool | Best for | |
|---|---|---|---|
| 1 | Matrix eIFU (formerly Dokspot) | Medical device and IVD manufacturers of any size, from a few product lines to high SKU portfolios. | Review |
| 2 | RealBit eIFU | Manufacturers selling mainly in Italy. | Review |
| 3 | SmartEIFU | Teams that only need document hosting. | Review |
| 4 |  eIFU.com (enLabel) | Labelling teams already working with enLabel. | Review |
| 5 |  tracekey | Teams that mainly need UDI data management. | Review |
| 6 |  Kallik | Enterprise labelling departments. | Review |
| 7 |  eIFUApp | Small manufacturers with simple needs. | Review |
Matrix eIFU (formerly Dokspot)
Best for Medical device and IVD manufacturers of any size, from a few product lines to high SKU portfolios.
- Hosting, version history and paper requests run as one managed service
- Paper requests handled for you within the legal deadline
- White label site on your own brand, current IFU in three clicks
- Unlimited products and IFU documents, with published pricing
- Validation templates supplied, ISO 9001 and ISO 27001 backed
- Support answers in an average of one hour
Matrix eIFU is a white label electronic instructions for use service: users reach the current instructions on your own branded site in three clicks. It is developed under an ISO 9001 certified quality management system, hosted in ISO 27001 certified data centres, and ships with templates for the eIFU quality assurance processes, including software and system validation reports.
The paper request in Article 5(3) and the version history required by Article 5 point (13) are handled by the same service that hosts the document. Audit logs, change records, approvals, paper orders, version management, website translations and geo fencing are modules of the platform, and Matrix One manages paper requests within the time the regulation sets.
Pricing is published on the product page, with unlimited products and IFU documents, and updates and maintenance included in the subscription.
- Published pricing
- Unlimited products and IFU documents
- Paper requests handled for you
RealBit eIFU
Best for Manufacturers selling mainly in Italy.
RealBit's footprint is concentrated in Europe, particularly Italy. Pricing is on request.
SmartEIFU
Best for Teams that only need document hosting.
SmartEIFU is a dedicated eIFU platform. Pricing is on request.
eIFU.com (enLabel)
Best for Labelling teams already working with enLabel.
Pricing varies by company size and document volume and is quoted on request.
tracekey
Best for Teams that mainly need UDI data management.
tracekey's eIFU pricing is on request; its UDI Manager is the core product.
Kallik
Best for Enterprise labelling departments.
Kallik is a broad labelling platform, with eIFU as one part of it. Pricing is on request.
eIFUApp
Best for Small manufacturers with simple needs.
eIFUApp offers a basic admin console and public portal. Pricing is on request.
Frequently asked questions
What are electronic instructions for use (eIFU)?
eIFU are instructions for use supplied in electronic form, usually a website or downloadable document, instead of a paper leaflet in the box. In the EU they are governed by Commission Implementing Regulation (EU) 2021/2226, as amended by Regulation (EU) 2025/1234.
Which devices can use eIFU in the EU?
Since Regulation (EU) 2025/1234 entered into force on 16 July 2025, eIFU are available for medical devices and accessories intended for professional use under Regulation (EU) 2017/745, for legacy devices under the Article 120 transitional provisions, and for Annex XVI products. A professional device that can reasonably be expected to be used by a lay person still needs paper instructions.
Do you still have to supply paper instructions on request?
Yes. Article 5(3) of Regulation (EU) 2021/2226 requires a paper copy, free of charge, within seven calendar days of a user's request.
What is the best eIFU software?
Matrix eIFU ranks first in this guide because hosting, version retention and the paper request run as one white label service with published pricing. (Matrix eIFU is made by the publisher of this guide.)
Does the FDA allow electronic labeling for devices?
Yes, for some devices. Section 502(f) of the FD&C Act, as amended in 2012, allows labeling for prescription devices intended for use in health care facilities or by health care professionals to be provided electronically, provided users can request a paper copy and receive it promptly at no additional cost.