Discover the latest European regulatory developments (2025/1234) on e-IFUs and their impact on the translation of medical device user manuals. Manufacturers, PRRCs and QARA professionals: everything you need to know to maintain compliance.
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Definition: e-IFUs (electronic Instructions for Use) are digital versions of the user manuals provided with medical devices.
Objectives of the transition: to modernise access to information, streamline document updates, and reduce environmental impact.
Regulatory context: Implementing Regulation (EU) 2021/2226 defines the conditions under which a manufacturer can provide IFUs in electronic form under the MDR (Regulation (EU) 2017/745).
Recent revision: Regulation (EU) 2025/1234, adopted on 25 June 2025, amends certain provisions of Implementing Regulation 2021/2226 on electronic instructions for use of medical devices.
Under Regulation (EU) 2021/2226, only certain devices intended for professional use can provide e-IFUs in place of paper versions. These include implantable devices, active implantable devices, fixed devices, accessories, and devices that display instructions via an integrated system.
The text also stipulates that the user can obtain a paper version on request, for safety or accessibility reasons.
With the 2025 revision (Regulation 2025/1234), the scope has been broadened, allowing devices intended for professional use to provide e-IFUs, even if they do not fall into the previously listed categories.
The European Commission clarifies this extension in a communication, stating: “healthcare professionals will be able to receive instructions for use of medical devices in electronic format, rather than solely on paper” (with the possibility of requesting a paper version).
In other words, all medical devices intended for professional use become eligible for e-IFUs, and manufacturers can provide the IFU in electronic form for these devices.
However, the extension does not require that all devices must necessarily transition to e-IFUs. For the time being, it is an authorised option, not an obligation.
In any case, it is important to ensure that technical and regulatory requirements are met. For each device, it is necessary to ensure:
1. Its intended use (professional vs. non-professional).
2. Its ability to meet requirements for accessibility, version control, language, and traceability.
3. The possibility of providing a paper version on request.
In June 2025, the Commission adopted Regulation (EU) 2025/1234, amending Implementing Regulation 2021/2226 to adapt the e-IFU framework to technological developments and feedback from professionals.
This reform lifts some of the limitations related to Annex XVI (certain listed non-medical devices) and broadens the use of e-IFUs to include all devices intended for professional use.
The Commission also published a communication highlighting that this measure aims to “simplify the instructions for use of medical devices” and promote the digitalisation of healthcare systems.
Before the regulation was adopted, a public consultation was launched at the beginning of 2025 to gather the views of manufacturers and professionals on the extension of e-IFUs.
Furthermore, some key industry players, such as MedTech Europe, called for the widespread adoption of e-IFUs for all devices for professional use.
The MDR requires that instructions and information, including IFUs, be provided in the languages required by the Member State in which the device is placed on the market.
The European Commission has published a document entitled “Overview of language requirements for manufacturers of medical devices”, listing the languages officially required by each country for instructions for use and accompanying documents.
In practice, this means that for an e-IFU, the electronic version must be available in the languages required by the target markets, with the same level of compliance as the paper version.
Any modification or update to a translated e-IFU must comply with the same validation, version control and traceability procedures as the original version.
The PRRC (Person Responsible for Regulatory Compliance) must ensure that electronic versions (and their translations) meet MDR requirements, particularly in terms of accessibility, safety, updates and traceability. The role of the PRRC is defined in the MDR and its guidance documents (see MDCG guidance on Article 15).
QARA teams must integrate processes for managing digital versions, ensure linguistic validation, coordinate updates with specialised translators, and ensure consistency across all language versions.
It is essential that PRRCs and QARA teams implement documented procedures covering the e-IFU lifecycle, including creation, translation, validation, publication, and withdrawal or modification.
Integration into a document management system (DMS) or a computer-assisted translation (CAT) tool is almost essential to manage versions, translation memories, approved glossaries, and ensure terminological consistency.
Translators themselves must specialise in the medical/medical device field, use regulatory glossaries, follow harmonised terminology, and understand compliance requirements.
In a frequently changing documentation environment, involving regulatory updates, safety alerts, etc., responsiveness is of critical importance: updated versions must be distributed quickly, whether in paper or digital format.
In this sense, language service providers and translators are strategic partners. They must be able to respond quickly and provide technical solutions to streamline document updates.
Linguistic compliance of e-IFUs follows the same principles as for paper versions. To ensure maximum linguistic compliance of IFUs, it is strongly recommended to implement a translation + editing process by native experts specialised in the medical field, who are familiar with regulatory constraints.
Maintain a centralised, validated multilingual glossary, including the device's technical terminology.
Ensure version traceability: keep a record of all versions, modifications, and validations in each language.
Implement a structured quality control process, including consistency tests, verification of hyperlinks, and verification of cross-references across all language versions.
Document the e-IFU lifecycle in the technical file, including translation decisions, published versions, and justifications for updates.
Eur-Lex: to access regulations, notably Implementing Regulation (EU) 2021/2226 and Regulation (EU) 2025/1234.
European Commission – healthcare/medical devices: “New Regulations” page on medical devices in Europe.
MDCG – guidance documents: the official page compiling MDCG-endorsed documents (guidances, Q&As, etc.).
Commission documents – “Overview of language requirements”: for language obligations by Member State.
Commission communications & news: notably “Commission simplifies instructions for use of medical devices” (25 June 2025) detailing e-IFU modifications.
Professional organisations (MedTech Europe, etc.): they publish position papers and analyses on the evolution of e-IFUs.
Are your e-IFUs available in electronic format, in accordance with the criteria set out in Implementing Regulation 2021/2226 and its 2025/1234 amendments?
Do your translations comply with the languages required by the target markets (cf. “Overview of language requirements”)?
Do you have a validated multilingual glossary shared across all languages?
Do you have a document management system or CAT tool in place to manage versions, updates, and translations?
Is the validation cycle (source → translation → editing → publication) documented and traceable?
Will post-market modifications or alerts be translated quickly and deployed in all relevant languages?
Does the technical file include a record of electronic versions and translations?
Are PRRCs and QARA teams trained in the specifics of e-IFUs (processes, responsibilities, compliance)?
