Global eIFU Regulations: A Region-by-Region Compliance Guide

What Is eIFU?

eIFU refers to electronic Instructions for Use – digital versions of the traditional paper manuals that accompany medical devices and IVDs. They are hosted online, integrated in devices, or delivered via storage media, offering benefits like sustainability, faster updates, and enhanced accessibility.

European Union

Under the EU’s MDR (EU 2017/745) and Implementing Regulation EU 2021/2226, eIFUs are permitted for certain devices:

• Implantable and active-implantable devices
• Fixed-installed devices
• Devices with built‑in display systems

Key requirements include:

• Targeting professional users only
• Aligning with documented risk assessments (usability, environment, tech access, backup options)
• Clearly indicating on label that IFU is in electronic form
• Maintaining eIFU online for at least 10–15 years and preserving historical versions
• Providing them in local EU languages

United States

The FDA permits eIFUs for prescription devices and IVDs in professional settings under 21 U.S.C. § 352(f) (amended FD&C Act).

Conditions:

• Must comply with all legal labeling standards
• Users must be able to request a physical copy at no cost and receive it promptly

Formats can include website downloads, CDs, USB media, or device-integrated displays

Canada

Health Canada allows optional eIFUs for medical devices not sold to the general public:

• They must satisfy all info under section 21(1) of the Medical Devices Regulations
• eIFUs may be hosted online or delivered via electronic media
• Paper copies must remain available on request

Brazil

Per RDC 206/2006, eIFUs are allowed, except for:

1. Equipment/materials for domestic use by laypersons
2. IVDs for self-testing, remote labs, calibrators

Allowed cases require full compliance with printed IFU content

Saudi Arabia

According to the MDS–G10 guidance (2015):

• Professional-user devices: eIFU is permitted
• Lay-user devices: Must include paper IFU
• Users must be able to easily access and request a paper version

Australia

The TGA allows optional eIFU for professional-use devices:

• Devices sold to general public must include a paper IFU, though electronic versions are allowed in addition
• Users must be able to request a paper copy without delay or cost

International Standards

Several global frameworks support eIFU implementation:

• ISO 20417: Specifies essential info to be provided by manufacturers, accommodating both paper and eIFU formats in line with MDR/IVDR
• IMDRF guidance also influences eIFU requirements (e.g., in EU and global convergence) .

Regulatory Summary Table

Benefits & Considerations

• Efficiency & sustainability: cost savings, reduced waste, instant updates
• Enhanced usability: easier navigation, accessibility features
• Regulatory alignment: greater flexibility while maintaining compliance
• Key considerations:
  • Validated electronic platforms
  • Robust version tracking
  • Documented risk analyses
  • Clear user guidance and offline contingencies

Final Thoughts

The global regulatory landscape is moving decisively toward electronic IFUs, especially for professional-use medical devices and IVDs. While rules vary by jurisdiction, the overarching principles remain:

• Paper IFUs must still be available on request
• Platform integrity and security are essential
• Device-specific and user‑targeted risk assessments are critical

By meeting these requirements, manufacturers can confidently leverage eIFUs to achieve compliance, improve user experience, and reduce environmental impact.

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