Can You Replace a Printed IFU With an Electronic One Under Regulation 2021/2226
- 2 days ago
- 5 min read
Yes. You can replace a printed instructions for use (IFU) with an electronic one, but only for the devices Regulation (EU) 2021/2226 covers and only after a documented risk assessment. Going electronic changes the medium, not the language duty. MDR Article 10(11) still requires the IFU in every official language of each member state where you place the device.
AD VERBUM is an EU-hosted AI+HUMAN hybrid translation company that produces and version-controls electronic IFU content in 150+ languages under ISO 13485 and ISO 17100, with certified medical linguists and no public-cloud processing. We keep every language version of your eIFU consistent, dated, and audit-ready for the full retention period the regulation sets.
What Regulation (EU) 2021/2226 permits
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 sets the rules for electronic instructions for use under the Medical Device Regulation (Regulation (EU) 2017/745). It replaced Regulation (EU) 207/2012, the older eIFU rule written for the previous directives. An electronic IFU is the instructions shown in electronic form by the device, held on portable storage supplied with the device, or delivered through software or a website.
The rule gives you an option, not a default. You may drop the paper leaflet only where the regulation allows electronic delivery, and only when you meet each condition attached to it. Miss one condition and the paper IFU stays mandatory.
Which devices qualify for an electronic IFU
Two things decide eligibility: the device type and who uses it. The original Article 3 list covered professional-use devices where lay use is not reasonably foreseeable:
implantable and active implantable devices and their accessories
fixed installed medical devices and their accessories
devices fitted with a built-in system that displays the instructions
software, where the electronic form is allowed even when lay persons use the device
That scope was widened. Regulation (EU) 2025/1234, in force 16 July 2025, allows electronic IFUs for all medical devices intended for professional use, including the Annex XVI products without a medical purpose when they are for professional use. The Commission based the change on a 2024 survey in which healthcare professionals preferred electronic instructions to paper.
The conditions you have to meet
Electronic delivery carries obligations that paper does not. Under Article 5 and the surrounding rules, you must:
run a documented risk assessment showing the electronic IFU keeps or improves the safety level of a paper IFU, covering user knowledge, the use environment, and protection against tampering
state clearly on the packaging or the device where the electronic IFU is found
publish the IFU on a website in each language required by the member states where you sell, with the current and previous versions and their dates
supply a paper copy on request, free of charge, within 7 calendar days
keep the electronic IFU available for 10 years after the last device is placed on the market, and at least 2 years after the expiry of the last unit for devices that carry an expiry date
A PDF dropped onto a company page does not meet these terms. The website itself is a regulated deliverable, and every language on it has to match the approved source.
Why electronic does not cut your translation work
The medium changed. The language rule did not. MDR Article 10(11) and Annex I Section 23.1(d) require the IFU in an official language set by each member state where the device is made available, so a device sold across the EU still needs the full set of national languages. Sweden expects Swedish, Poland expects Polish, and an electronic format exempts neither.
An electronic IFU can raise the translation burden rather than lower it. The website must hold every required language, each version dated and retained for years, so one wording change ripples across all of them at once. The same discipline applies to the Safety and Clinical Performance Summary and to any labelling that points to the eIFU.
This is where we at AD VERBUM fit. We ingest your existing Translation Memory and Term Base, generate constrained output on client-tuned open-weight models, and route every language through certified medical reviewers under ISO 13485 before it reaches your eIFU site. Terminology stays consistent across versions through governed sign-off, and every change is traceable.
Where teams get eIFU wrong
Most eIFU problems trace back to a few avoidable mistakes:
assuming the electronic form removes a language, when the national-language set under MDR Article 10(11) stays in full
treating machine translation output as final, which can carry semantic errors into a published IFU and stall CE marking.
letting website language versions drift apart after a source update, so one market reads an outdated instruction
storing controlled or patient-linked content on public-cloud tools without EU data residency.
Each of these is a documentation failure a notified body or competent authority can act on, not a formatting quibble. The same expectations carry into IVDR device documentation before the 2027 deadlines.
Our medical device translation services
Our translation services for regulated sectors run on ISO 27001 and ISO 42001 certified, EU-hosted infrastructure, with no reliance on public cloud tooling for core processing. Every project runs through our AI+HUMAN hybrid workflow: we ingest client Translation Memories and Term Bases first, our proprietary LLM-based LangOps System generates output constrained by client terminology on client-tuned open-weight models, and our certified subject-matter experts review for technical accuracy and regulatory compliance. Our QA is aligned to ISO 17100 and ISO 18587, with sector-specific requirements such as the Medical Device Regulation (Regulation 2017/745) and Regulation (EU) 2021/2226 electronic-IFU handling applied where relevant. We serve Life Sciences, Legal, Finance, Defense, and Manufacturing clients across 150+ languages with 3,500+ subject-matter linguists. For teams managing audit-sensitive content, contact us to discuss your security and compliance requirements directly.
FAQ
Can you legally replace a paper IFU with an electronic one in the EU?
Yes, for eligible devices under Regulation (EU) 2021/2226 and only after a documented risk assessment showing the electronic IFU keeps or improves the safety of a paper one. The option does not apply to every device, and each condition in the regulation has to be met.
Does an electronic IFU change the language requirement?
No. MDR Article 10(11) and Annex I Section 23.1(d) still require the IFU in the official language set by each member state where the device is sold. An electronic format changes delivery, not the national-language obligation.
Which devices can use an electronic IFU after Regulation (EU) 2025/1234?
From 16 July 2025, all medical devices intended for professional use, including Annex XVI products without a medical purpose that are for professional use. This widened the earlier Article 3 list of implantable, fixed installed, and built-in-display devices plus software.
Do you still have to provide a paper IFU?
Yes, on request. Under Regulation (EU) 2021/2226, as amended by Regulation (EU) 2025/1234, the manufacturer must supply a paper copy free of charge within 7 calendar days of the request.
How long must an electronic IFU stay available?
The electronic IFU must remain available for 10 years after the last device is placed on the market. For devices with an expiry date, other than implantable devices, it must stay available at least 2 years after the expiry of the last produced unit.
Who should translate an electronic IFU?
A provider certified for medical-device work. AD VERBUM translates eIFU content under ISO 13485 and ISO 17100 with certified medical reviewers and EU-hosted infrastructure, so every language version stays consistent and audit-ready across the retention period.
