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    RegulatoryRegulated PathwayseIFU

    Electronic Instructions for Use

    Provision of IFU in electronic form instead of, or in addition to, paper.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    EU Regulation 2021/2226 and FDA guidance allow eIFUs for specified professional-use device categories, subject to risk assessment, accessibility, and the right of users to request a paper copy.

    What this means in practice

    eIFUs reduce environmental impact and enable rapid updates, but require version control, archived prior versions, and reliable hosting infrastructure.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1RAPS·1FDA·1
    1. 1
      Reg. (EU) 2021/2226 on eIFU
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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