Medical Device Instructions for Use (IFUs)

Guiding correct product use across care settings

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Introduction

To ensure medical devices are used safely and effectively, manufacturers must provide clear, accurate, and accessible Instructions for Use (IFUs). IFUs are critical to the device’s safety and compliance profile—they guide healthcare professionals and patients on proper usage, help prevent misuse, and support regulatory approval.

In this article, we explore the role of IFUs in medical device manufacturing, key regulatory requirements, and international standards that shape their content and presentation.

What is an IFU?

An Instruction for Use (IFU) is a document provided by the manufacturer that accompanies a medical device and explains how to use it correctly and safely. Depending on the type of device and applicable regulations, the IFU may be provided in paper form, electronically (eIFU), or both.

The content of an IFU typically includes:

  • Intended use / intended purpose
  • Indications and contraindications
  • Warnings and precautions
  • Step-by-step instructions
  • Maintenance and storage guidance
  • Disposal and sterilisation instructions (if applicable)
  • Contact information for the manufacturer

An IFU is not just a formality—it’s essential for:

  • Supporting user training
  • Reducing the risk of misuse or harm
  • Meeting regulatory and legal obligations

When is an IFU required?

Whether an IFU is mandatory depends on the device’s risk classification, complexity, and jurisdiction-specific regulations. Generally, high-risk and complex devices (e.g., implants, surgical instruments, and active devices) require detailed IFUs. Low-risk devices may not require an IFU if they can be used safely without additional instructions, as determined by the manufacturer and regulators.

What is the difference between an IFU and a user manual?

The terms Instructions for Use (IFU), user manual, and operations manual are often used interchangeably in the medical device industry. Still, they have distinct meanings and regulatory implications, especially regarding compliance.

  • The IFU is a regulatory deliverable designed to provide minimum required information for safety and performance, often dictated by standards and laws.
  • The user manual or operations manual is typically a more comprehensive and practical guide, focusing on usability, operation, and maintenance, and may include content beyond what’s legally required in an IFU. It is designed to help the end user (whether a healthcare professional or layperson) understand how to operate the device effectively and may go into greater detail than an IFU. User or operations manuals typically include:
    • Detailed setup and installation instructions
    • Step-by-step operational procedures
    • Maintenance, servicing, and troubleshooting guidance
    • More comprehensive diagrams or illustrations
    • Advanced functions or optional configurations
    • Guidance on software or user interface features (if applicable)

While user manuals often contain content that overlaps with the IFU, they are not always structured or written to meet regulatory content requirements. A user manual might accompany the device as an additional resource, but it doesn’t replace the IFU where an IFU is required by law.

In some devices—particularly complex ones like imaging systems, surgical robots, or analysers—the IFU and user manual may be integrated into one document. However, manufacturers must ensure that wherever IFU content is provided, it meets the specific regulatory requirements of the target market.

Regulations and standards for IFUs

Regulatory agencies and standards bodies worldwide have developed detailed requirements for medical device labelling, including IFUs. A comprehensive list of regulations and guidance documents can be found at the end of the article (see Resources).

    The Medical Device Regulation (EU 2017/745 - MDR) and in vitro Diagnostic Medical Device Regulation (EU 2017/746 - IVDR) set detailed requirements for IFUs.

    Annex I, Chapter III, Section 23 of MDR outlines the information to be supplied by the manufacturer, including IFU content:

    • Intended purpose
    • User and patient target groups
    • Instructions for safe use, including preparation, calibration, and maintenance
    • Warnings, precautions, contraindications
    • Expected performance and side effects
    • Materials that may cause sensitisation or allergies
    • Residual risks and appropriate mitigation measures
    • Sterility and re-sterilisation guidance
    • Storage and handling conditions

    Electronic IFUs (eIFUs) are permitted for certain devices under specific conditions. These conditions were detailed initially in Commission Regulation (EU) No 207/2012, which was subsequently repealed and replaced by Regulation (EU) 2021/2226. Currently, manufacturers may provide e-IFU instead of paper IFU, for:

    • Implantable and active devices
    • Fixed installed medical devices
    • Medical devices fitted with a built-in system that visually displays the IFU.

    This is a fast-moving issue, and the EU has recently concluded a consultation to amend Regulation 2021/2226 through Draft implementing regulation - Ares(2025)1431476 in 2025.

    The U.S.FDA requires labelling, including IFUs, to meet the requirements of:

    FDA expectations for IFUs include:

    • Clear identification of the device, manufacturer, and intended use
    • Directions for use sufficient for a layperson or professional to use the device safely
    • Warnings, precautions, and potential adverse effects
    • Instructions for handling, cleaning, and sterilisation (if applicable)

    The FDA also provides specific guidance for certain devices (e.g. reusable medical devices, home-use devices) where IFUs play a central role in safety.

    Several international standards provide detailed guidance on IFU content, format, and symbols.

    The International Medical Device Regulators Forum (IMDRF) offers harmonised principles on labelling and IFU content to support regulatory convergence:

    The future of IFUs: digital versus paper formats

    The shift from paper to electronic instructions for use (eIFU) is accelerating, driven by clear benefits for industry stakeholders and users. However, it also brings new challenges that manufacturers must carefully consider.

    • One of the major advantages of eIFU is that, unlike paper instructions, they cannot be easily misplaced, damaged, or destroyed. As long as the instructions are available online, end users can access them whenever needed. This provides greater reliability, especially when a paper IFU might be lost during device installation or relocation. However, a primary concern is accessibility: without an internet connection, users may be unable to access the instructions unless they’ve downloaded them in advance. Network outages can occur even in regions with good connectivity, which could be critical depending on the device and its use environment.
    • eIFUs are often considered a more appropriate medium for digital products. The growth of connected health devices, medical device software and apps is another force driving the shift to electronic IFUs and training materials.
    • Another benefit is the ease and speed with which eIFU can be updated. When safety information changes (e.g. as a result of post-market surveillance) manufacturers can update the eIFU immediately, ensuring that users always have access to the most current guidance.
    • For manufacturers, eIFU can reduce costs by eliminating the need to print and package physical instructions. This has environmental benefits and can even help lower sterilisation dosages by reducing the paper bulk included with the device.
    • Finally, eIFU removes physical space limitations, making it easier to offer more comprehensive instructions in multiple languages without concern for fitting everything onto a printed sheet. The digital format also allows for more creative and interactive communication methods, such as videos, animations, voice instructions, and links to further resources. Interactive instructions can benefit more complex devices. These can be valuable tools for integrating user training with healthcare provider and patient engagement. However, there are also design complexities to address. For devices that display eIFU on a built-in screen, users may face difficulties switching between the instructions and the operational display. Additionally, information that is always visible on paper—such as safety warnings—might become less prominent when translated into a digital, scrollable format. This could lead to important details being overlooked at key moments.

    As manufacturers consider eIFU, they must balance these benefits and challenges to ensure that instructions remain clear, accessible, and safe for all users.

    Best practices for developing compliant IFUs

    • Risk-based content: The content and detail in the IFU should be proportional to the device’s risk profile. Complex and high-risk devices typically require more extensive instructions.
    • Human factors and usability testing: Manufacturers should validate that the IFU is understandable and usable through usability engineering conforming to IEC 62366-1. Different user types may use medical device products, including professionals, patients, or caregivers, each requiring tailored instructions. It’s important to consider differences between user profiles and validate the IFU using appropriate usability testing or human factors testing studies.
    • Multi-jurisdictional compliance: can be a challenge for manufacturers. Differences between markets mean IFUs must be adapted for each market. Provide IFUs in the languages required by local regulations and ensure they are legible, with clear diagrams where appropriate. Use standard symbols based on ISO 15223-1 and ensure eIFU solutions meet local regulatory requirements (e.g. easy user access, printed copy on request).
    • Documentation and change control: The IFU is a component of a product’s labelling and forms part of the device’s technical documentation. Changes may be required throughout the product’s lifecycle due to design changes or issues revealed through post-market surveillance (e.g., new warnings, clarified steps). These changes must be subject to change control processes and documented appropriately.

    When designing an IFU, reviewing IFUs or user manuals from similar products can be very helpful in getting a sense of common content, structure, and formatting that meets regulatory expectations. However, many manufacturers don’t publish their IFUs or manuals openly online, making benchmarking tricky. This useful resource is a guide to finding IFUs and user manuals online.

    Conclusion

    IFUs are critical to medical device compliance, providing the essential information regulators require to ensure devices are used safely and effectively. A well-designed IFU helps demonstrate that the manufacturer has identified and mitigated risks through clear communication of intended use, warnings, and instructions. Beyond compliance, IFUs play a vital role in supporting users, whether healthcare professionals or patients, by guiding them through proper setup, operation, and maintenance. This ultimately reduces the likelihood of use errors and contributes to better outcomes.

    Resources

      European Union Medical Device Coordination Group (MDCG)

      U.S.A Food and Drug Administration

      Health Canada

      Australia Therapeutic Goods Administration (TGA)

      U.K. Medicines and Healthcare products Regulatory Agency (MHRA)

      International Medical Device Regulators Forum (IMDRF)

      European Union MDR/IVDR

      U.S.A Food and Drug Administration

      Health Canada: Medical Devices Regulations SOR/98-282, Part 1, Sections 21-23 – Labelling

      Australia Therapeutic Goods Administration (TGA): Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 1, Clause 13.1

      U.K. Medicines and Healthcare products Regulatory Agency (MHRA): UK Medical Devices Regulations 2002 (as amended), Part II, Section 13 – Information supplied with device

      Japan (PMDA): Medical device labelling must comply with Pharmaceutical and Medical Device Act (PMD Act), including Japanese language requirements

      China (NMPA): Labelling requirements under Medical Device Supervision and Administration Regulation, with mandatory Chinese language labelling

      International Standards

      CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).

      Competent Authority (CA): A national regulatory body responsible for regulating and overseeing the safety, efficacy, and quality of medical devices within its jurisdiction. Also see Regulatory Authority.

      Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.

      Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.

      FDA Approval: The process by which the U.S. Food and Drug Administration (FDA) officially recognises that a medical device is safe and effective for its intended use.

      Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.

      Healthcare Professional: An individual trained and licensed to provide medical care, treatment, and advice to patients, encompassing a range of roles such as physicians, nurses, pharmacists, and allied health professionals.

      Healthcare Provider: An individual or organisation licensed or otherwise authorised to deliver medical, nursing, dental, or other healthcare services to patients or clients.

      Human-Device Interaction: The interaction between the user and the medical device, including how the user perceives, interprets, and responds to the device’s signals and controls.

      Human Factors Engineering (HFE): The application of knowledge about human abilities, limitations, and other characteristics to the design of medical devices, systems, and environments to ensure safe, comfortable, and effective use. Also see Usability Engineering.

      Indication of Use: A concise statement specifying the medical conditions or purposes for which the medical device is intended to be used, as approved by regulatory authorities.

      Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.

      Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.

      International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).

      in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.

      ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.

      Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)

      Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.

      Notified Body (NB): An organisation designated by a country authority to assess the conformity of certain products before being placed on the market, ensuring they meet applicable regulatory requirements and standards.

      Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.

      Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.

      Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.

      Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.

      Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.

      Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.

      Sterilisation: A process designed to destroy all microbial life, including spores, on a medical device.

      Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.

      Unique Device Identification (UDI): A system that marks and identifies medical devices within the healthcare supply chain.

      Universal Health Coverage (UHC): Ensuring all individuals and communities receive the necessary health services without suffering financial hardship.

      Usability Engineering: The process of designing medical devices to ensure they are safe, effective, and easy to use by intended users under specified conditions.

      Usability Testing: The evaluation of a medical device by testing it with real users to identify usability issues and improve the design.

      Use Environment: The settings and conditions under which a medical device is used, such as hospitals, clinics, or home settings.

      Use Error: Errors that occur during the use of a device due to poor design, leading to incorrect operation by the user.

      Use Scenario: A detailed narrative describing the sequence of actions that a user would take to complete a task with the medical device in a specific context.

      User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.

      User Requirements: The requirements and preferences of the intended users, which must be considered and addressed in the device design. Also known as User Needs or Customer Specifications.

      Validation: Confirmation by examining and providing objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

      Updated on 01 Jan 0001