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    Labeling

    All written, printed, or graphic matter on or accompanying a device.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed September 19, 2026

    Definition

    Per FD&C Act, labeling includes any written, printed, or graphic matter accompanying a medical device, encompassing the IFU, package labels, and patient information leaflets. Under the Federal Food, Drug, and Cosmetic Act, labeling is broader than the label itself: it includes all written, printed or graphic material on or accompanying the device, such as IFUs, packaging, inserts and, in many cases, websites and promotional materials. False or misleading labeling makes a device misbranded. In the EU, labeling requirements are set in MDR Annex I, Section 23, and symbols are commonly drawn from ISO 15223-1.
    What the regulation says
    Under 21 CFR Part 801, FDA defines labeling broadly to include all written, printed, or graphic matter accompanying a device, encompassing items like instructions for use (IFU), packaging, and promotional materials. Similarly, the EU MDR (Regulation (EU) 2017/745) details essential requirements for information supplied with the device in Annex I, Chapter III, emphasizing aspects like symbols, electronic instructions, and language requirements.

    What this means in practice

    Labeling errors are a leading cause of recalls and Form 483 citations. EU MDR adds harmonized symbols and electronic IFU rules.

    Examples

    • A manufacturer includes a detailed instruction for use (IFU) booklet inside the medical device packaging, which details operating procedures and maintenance schedules.
    • The outer carton of a sterile medical device displays a symbol indicating "do not resterilize" and the universally recognized symbol for "use-by date."
    • A company provides a dedicated section on its website with downloadable electronic Instructions for Use (eIFU) for its diagnostic equipment, accessible after accepting terms and conditions.
    Common pitfalls
    • •A common pitfall is assuming labeling only refers to the physical label on the device itself; it includes all accompanying information.
    • •Companies often fail to translate labeling accurately and appropriately for all target markets, leading to non-compliance.
    • •Inconsistent information across various labeling components (e.g., IFU, website, promotional materials) can lead to regulatory scrutiny.
    • •Overlooking the need for version control and proper document management for all labeling elements is a frequent mistake.
    • •Failing to validate electronic IFU systems for accessibility, readability, and security can result in regulatory issues.

    Frequently asked questions

    The primary purpose is to provide users with essential information for safe and effective device use, including indications, contraindications, warnings, precautions, and operating instructions.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 2Regulator guidance and consensus· 2Tier 4Trade press and expert commentary· 1
    Link health: 3 verified· last checked 2026-06-20
    IMDRF·1RAPS·1FDA·1
    1. 1
      IMDRF Documents
      Tier 2 Verified
      IMDRFimdrf.org
    2. 2
      RAPS Regulatory Focus
      Tier 4 Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Tier 2 Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.