Instructions for Use (IFU) for Medical Devices Under EU MDR
Clear, compliant Instructions for Use that meet Annex I, trace back to your risk file and hold up in usability testing and Notified Body review.
Regulatory Expertise
In-depth knowledge of EU MDR and the global regulatory landscape.
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Actionable solutions tailored to your product and business needs.
Documentation Guidance
Clear, structured and audit-ready documentation support.
Market Access
Smooth and safe access to the European market.
What Is an IFU?
The IFU is the information supplied by the manufacturer to tell users how to use a device safely and as intended. For active devices it is often called a user manual. The MDR sets out its content in Annex I, Chapter III, Section 23.4, alongside the labelling requirements.
An IFU must be supplied with every device. The only exception is for Class I and Class IIa devices that can be used safely without one. Because the IFU is a core part of your technical file, our IFU work sits within our wider support for EU MDR technical documentation.Under Regulation (EU) 2017/745, the Instructions for Use (IFU) are part of the device itself from a regulatory point of view. They are reviewed as part of your technical documentation, tested as part of your usability evaluation and relied on as a risk control measure. As an EU MDR consultant, 3i Concept helps medical device and drug-device combination product manufacturers prepare IFUs that are accurate, usable and consistent with the rest of the technical file.
Services
- Technical Services For Design And Development Of Medical Devices
- QMS Development and Support
- Risk Management Service
- Technical Documentation Services
- Medical Device Labelling
- Audit Readiness Plan
- Design Control Requirements for Drug-Device Combination Products
- EU Medical Device Regulation
- Medical Device Testing Service
What the IFU Must Include
Section 23.4 of Annex I requires the IFU to cover, where applicable:
Device Identification & Purpose
Device name, manufacturer and Authorised Representative details, intended purpose, indications, contraindications, target patients and intended users.
Benefits, Risks & Warnings
Expected clinical benefits and performance, residual risks, warnings, precautions and undesirable side effects.
Correct Use & Handling
Preparation, installation, calibration and maintenance, sterilisation or reprocessing instructions, and safe disposal of the device and accessories.
Safety Reporting & Document Control
A notice on reporting serious incidents, a reference to the SSCP for implantable and Class III devices, and the IFU's date of issue or latest revision.
eIFU, Language and Symbols
the MDR also sets rules on the IFU’s format, language and symbols.
Electronic IFU (eIFU)
Commission Implementing Regulation (EU) 2021/2226 allows electronic instructions only for certain devices intended for professional users, such as implantable device. The manufacturer must carry out a documented risk assessment.
Language
Under Article 10(11), the IFU must be in the official language(s) required by each Member State where the device is made available.
Symbols and standards
EN ISO 15223-1:2021 covers symbols, and EN ISO 20417:2021 covers the information supplied by the manufacturer.
IFU as Part of Risk Management and Usability
The IFU is not written in isolation. Under GSPR 4, information for safety is the last option in the risk control hierarchy, after design and protective measures. Every warning in the IFU should therefore trace back to your risk management file.
Under IEC 62366-1, the IFU is part of the user interface and should be validated in your summative usability evaluation, which we support through our medical device validation services. Notified Bodies check that the IFU, risk file and usability file are consistent.
IFU for Drug-Device Combination Products
For integral products regulated as medicines, such as prefilled syringes, pen injectors and auto-injectors, the device instructions sit within the medicinal product’s package leaflet under Directive 2001/83/EC. They still need to reflect the device’s usability and risk evidence, which is assessed for the Article 117 Notified Body Opinion.
Through our drug device combination product consulting service, 3i Concept bridges the gap between pharmaceutical and device documentation, drawing on direct experience with these products.
Common IFU Challenges
- Warnings that don't trace back to the risk management file.
- IFUs that were never tested with representative users.
- Outdated standards and symbols carried over from MDD-era IFUs.
- Using eIFU for devices that don't qualify under Regulation 2021/2226.
- Translations that change the meaning of safety-critical instructions.
IFU Services
- IFU Drafting: device-specific IFUs prepared against Annex I, Section 23.4.
- IFU Gap Assessment: an MDR gap analysis of existing or MDD-era IFUs against current requirements.
- Risk and Usability Alignment: tracing warnings to your risk file and supporting usability validation.
- Symbols and Labelling Review: applying EN ISO 15223-1 and EN ISO 20417 correctly.
- eIFU Support: assessing eligibility and setting up compliant electronic instructions.
- Translation Review: checking that translated IFUs keep safety-critical meaning in every target language.
- Combination Product Instructions: device content for package leaflets and Article 117 submissions.
Our Process
Review
We assess your current IFU, label and risk file against Section 23.4
Draft or revise
We prepare or update the IFU, with every warning traced to the risk file
Validate
We align the IFU with your usability evaluation and confirm symbols and languages.
Integrate
We cross-check the final IFU against your technical documentation before submission.
Subhash Meena
Medical Device & Drug-Device Combination Product Expert
Why Choose 3i Concept
Our IFU work is led by Subhash Meena, a medical device and drug-device combination product expert with 15+ years of experience across Meril Life Sciences, Sun Pharmaceutical Industries, Amneal Pharmaceuticals and Dr. Reddy’s Laboratories. His hands-on work with pen injectors, auto-injectors and prefilled syringes means your instructions are written by someone who understands both the device and how it is used.
15+
Year of Experience
4
Leading Companies
NB + USFDA
Direct Fillings
Frequently Asked Questions
The Instructions for Use are the information a manufacturer supplies so users can operate a device safely and as intended. Under the EU MDR, the IFU content is set out in Annex I, Chapter III, Section 23.4.
Yes, for almost all devices. The only exception is for Class I and Class IIa devices that can be used safely without instructions, under Section 23.1(d).
Device identification, intended purpose, clinical benefits, residual risks and warnings, correct use and maintenance, sterility or reprocessing information, disposal, incident reporting, an SSCP reference where applicable, and the date of issue.
Only for certain devices intended for professional users, such as implantable devices, fixed installed devices and software, under Regulation (EU) 2021/2226. A paper copy must be supplied within 7 calendar days of a request.
The official language or languages required by each Member State where the device is made available, under Article 10(11) of the MDR.
Yes. In the US, device labelling, including directions for use, is governed by 21 CFR Part 801.
Warnings in the IFU are risk control measures, so they must trace back to your ISO 14971 risk file. The IFU is also part of the user interface under IEC 62366-1 and should be validated in usability testing.
Yes. An IFU that meets Section 23.4 is part of the technical documentation a Notified Body reviews. As your CE marking consultant, we make sure it meets this condition of certification.
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