Learn about compliant, user‑friendly Instructions for Use (IFUs) for medical devices and IVDs in the EU, aligning with strict MDR/IVDR requirements.
Instructions for Use (IFUs) serve as the main channel through which manufacturers convey critical information about the safe and effective operation of medical devices and in vitro diagnostic devices (IVDs). From labeling content and language requirements to formatting and warnings, IFUs must not only meet strict regulatory standards under the Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746) but also be clear, concise, and user‑friendly for healthcare professionals and patients alike.
As life science translation experts who regularly offer guidance to our clients on IFUs and regulatory compliance, we understand just how important they are for getting your medical devices on the global market. In this article, we will outline EU‑specific requirements, best practices for drafting compliant documentation, and practical considerations for multilingual deployment.
Contents
What Is An “Instructions for Use”?
An IFU document is the authoritative guide that accompanies every medical device and in vitro diagnostic (IVD) product placed on the market. It converts complex technical specifications into clear, step‑by‑step directions for intended users – whether they are healthcare providers or the patients themselves. A compliant IFU must include:
Product Identification and Manufacturer Details
- For support and reporting, the IFU must list the device’s trade name and type/model alongside the manufacturer’s:
- Full legal name
- Address
- Up-to-date contact information
Intended Use and Clinical Scope
- To guide appropriate use by specified user groups, clearly define:
- Medical purpose
- Target patient population
- Any contraindications
Device Description and Performance Profile
- Provide a brief overview of the device’s design and operating principle, highlighting the following:
- Key clinical benefits
- Validated performance metrics (e.g., sensitivity, specificity)
Environmental and Operational Requirements
- To ensure safe, accurate performance, state the minimum storage, transport, and operating conditions, such as:
- Temperature
- Humidity
- Power
- Installation constraints
Residual Risks, Warnings, and Precautions
- Summarize any remaining hazards not eliminated by design with:
- Concise warnings
- Required precautions
- Guidance on responding to malfunctions or error alerts
IFUs help prevent user errors, protect patient safety, and ensure reliable diagnostic and therapeutic outcomes. And, beyond safeguarding users, they are also crucial for maintaining compliance under the EU’s MDR and IVDR frameworks – we will address this shortly. User‑friendly IFUs simplify regulatory review, reduce the risk of recalls or market suspensions, and – when properly translated and localized – increase market access while reinforcing credibility.
At Conversis, our life sciences translation services ensure that your IFUs are appropriately translated for the country in which the device will be marketed. We can assist throughout each stage of development, not just once the IFU has been created, to help you maintain a high level of compliance.
Regulatory Framework for IFUs in the EU
Below is a side‑by‑side overview of the key IFU requirements under the MDR 2017/745 and the IVDR 2017/746:
| Requirement | MDR 2017/745 | IVDR 2017/746 |
|---|
| Legal Basis |
IFU is mandatory for all devices. |
IFU is mandatory for all IVDs. |
| Content Requirements |
Must cover intended purpose, indications, contraindications, warnings, step‑by‑step use, maintenance, troubleshooting, storage/transport, symbols glossary, UDI carrier guidance. |
Same core elements + IVD‑specific: test principle, specimen collection, performance characteristics (sensitivity, specificity), interpretation of results, quality‑control procedures. |
| Usability & Readability |
“Understandable by the intended user”. Validation through human factors/usability testing. |
Same “understandable” & usability‑engineering requirements. Emphasis on lay‑user comprehension for self‑testing or near‑patient IVDs. |
| Translation & Localization |
Must be translated into official languages of all EU countries where the device is marketed. |
Same multilingual obligation. Additional focus on ensuring self-test kit instructions are clear, easy to follow, and culturally appropriate. |
How Should IFUs Be Provided?
Single‑Copy Provision
When supplying multiple units of the same device (or different devices) to a single user or location, a manufacturer may provide just one physical copy of the IFU, provided that:
- Pre‑Agreement: The purchaser has expressly agreed in advance to receive only one copy.
- Free Access: Additional paper copies are made available upon request at any time, free of charge.
This approach reduces waste and administrative burden while remaining fully compliant with both:
- MDR 2017/745 (general requirement that IFUs accompany each device, with flexibility for consolidated distribution).
- IVDR 2017/746 (same single‑copy allowance under Annex I, Chapter III).
Electronic Instructions for Use (eIFU)
Professional-use devices may forego paper IFUs altogether and instead supply fully electronic instructions, except for devices intended for near‑patient testing. Annex I, Chapter III, Section 20 of the IVDR states:
“When the device is intended for professional use only, instructions for use may be provided to the user in non‑paper format (e.g., electronic), except when the device is intended for near‑patient testing.”
There are some key considerations for deploying eIFUs, most notably:
- Accessibility: The manufacturer must ensure users can easily access, download, view and print the eIFU (e.g., via a secure portal).
- Version Control: Electronic versions must be maintained, updated and archived just like paper IFUs, with clear version/date identifiers.
- Notification: Users should be informed (e.g., on the device label) how to obtain the eIFU and any system requirements needed to view it.
What Are the Benefits of Using an eIFU
For both medical device manufacturers and end-users, there are multiple benefits of using an eIFU over paper-based instructions, including:
- eIFUs are permanently available online, so they can’t be lost or damaged like paper manuals.
- Going digital cuts printing, packaging and shipping costs – and reduces the extra sterilization burden of paper.
- Safety updates can be published instantly, ensuring users always see the latest information.
- Digital formats support rich media – animations, videos, voiceovers, and direct links to resources.
- There’s no paper‑size limit on languages, so you can offer instructions in as many languages as needed.
Are There Any Special Requirements for AI-Based Software?
If your device incorporates a high‑risk AI component, you should extend your IFU to include a clear description of:
- How the AI makes decisions
- Guidance on interpreting its outputs
- Explicit warnings about any residual risks to user rights or potential biases
This ensures that you align with recital 47 of the European Artificial Intelligence Act (AIA), which addresses how AI systems could have an adverse impact on public health and safety. Recital 47 states:
“To address the opacity that may make certain AI systems incomprehensible to or too complex for natural persons, a certain degree of transparency should be required for high‑risk AI systems. Users should be able to interpret the system output and use it appropriately.
High‑risk AI systems should therefore be accompanied by relevant documentation and instructions for use and include concise and clear information, including in relation to possible risks to fundamental rights and discrimination, where appropriate.”
Practical Tips for Efficient Multilingual IFU Development
Here are some useful tips to keep in mind when developing and deploying IFUs for medical devices across multiple languages:
- Form a Cross‑Functional Task Force: Involve Regulatory Affairs, Clinical Experts, UX Designers, and Translation Specialists from the outset. This ensures IFUs are not only accurate and compliant but also linguistically consistent and ready for localization.
- Involve Standardized Checklists and Templates: Develop or adopt MDR/IVDR-aligned checklists and document templates. Consistent structures make it easier to translate and guarantee every required section (e.g., indications, warnings, UDI) is captured across all language versions.
- Use a Content Management System (CMS) for Version Control: Host your IFU drafts in a CMS that tracks revisions, approvals, and publication dates. This enables efficient rollout of updates across languages, makes it easy to audit changes, and demonstrates compliance in multilingual contexts.
- Embed Iterative Usability Testing: Schedule quick, task-based reviews with representative end-users (e.g., nurses, lab techs, or lay-persons). Include native-language testers where possible to validate clarity, uncover linguistic ambiguities, and refine UI elements (icons, callouts, etc.) across different markets.
- Plan Translation and Localization Early: Integrate Translation Memory (TM) and terminology management tools into your workflow. Finalize core phrasing and structures before full localization to minimize rework and maintain consistency across all language versions.
For MDR- and IVDR-Compliant IFU Translations, Contact Our Specialists
Many medical device manufacturers only engage with a translation expert after their IFUs have been reviewed, delaying their progress. By partnering with us at the very start of your IFU development, we can ensure smoother, faster translations and a quicker pathway to market. Get in touch with our translation experts today to improve your process and confidently launch your product in international markets.
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