Supplying Electronic Instructions for Use (eIFU) for Medical Devices in Australia

1. Purpose and Scope of eIFU

The Therapeutic Goods Administration (TGA) allows electronic instructions for use (eIFU) instead of paper instructions for use (IFU) for specific higher-risk medical devices. This option reduces environmental impact, lowers costs, and aligns with global trends (e.g., EU MDR/IVDR provisions), while ensuring safety, performance, and usability are not compromised. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

eIFU is permitted only for:

• Implantable and active implantable medical devices
• Fixed medical devices with a mains electricity supply
• Devices intended for professional use only (not for lay use)

Paper IFU remains mandatory for devices intended for non-professional/lay users. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

2. Key Conditions for Supplying eIFU

Sponsors must meet all of the following requirements before supplying devices with eIFU:

• Conduct a documented risk assessment demonstrating that eIFU does not increase risk to patients or users compared to paper IFU.
• Ensure eIFU is provided in a reliable and secure electronic format (e.g., PDF) that preserves content integrity.
• Guarantee immediate and continuous access to the current version of eIFU for at least the expected lifetime of the device (typically 15 years for implants).
• Provide paper copies free of charge within 5 working days upon request from users or healthcare professionals.
• Include clear instructions on how to access eIFU (e.g., website URL, QR code) on the device label or packaging.
• Maintain records of eIFU versions and access logs for traceability. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

3. Risk Assessment and Justification

The risk assessment must consider:

• User competence (professional only)
• Device criticality (implantable/active)
• Potential consequences of delayed or incorrect access to instructions
• Reliability of electronic delivery (internet access, cybersecurity)
• Compatibility with common devices (e.g., smartphones, computers)

If risks cannot be adequately mitigated, paper IFU must be supplied. The assessment should be part of the technical documentation and available for TGA review. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

4. Labelling and Packaging Requirements

When supplying eIFU:

• The device label or outer packaging must clearly state that instructions are supplied electronically and include:
  • Website address or QR code for direct access
  • Statement that paper IFU is available on request
  • Any special access instructions (if applicable)
• Symbols from ISO 15223-1 may be used (e.g., symbol for “consult instructions for use” with electronic indication).
• Labelling must remain compliant with TGA requirements under the Therapeutic Goods (Medical Devices) Regulations. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

5. Accessibility and Retention Period

• eIFU must be accessible without requiring special software beyond standard PDF readers.
• Version control must ensure users always access the latest approved version.
• Retention period: at least the lifetime of the device (commonly 15 years for implants) plus any additional period specified in the risk assessment.
• Sponsors must notify users of significant updates to eIFU (e.g., via website alerts or direct communication where feasible). https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

6. Implementation and Transition

• eIFU may be introduced for eligible devices at any time, provided all conditions are met.
• For legacy devices already supplied with paper IFU, transitioning to eIFU requires a variation application if labelling changes.
• Sponsors should update their risk management files and technical documentation accordingly.
• The TGA does not require pre-approval for eIFU but may request evidence during audits or post-market reviews. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices

7. Practical Considerations and Best Practices

• Use secure, stable hosting platforms with redundancy and backup.
• Provide multilingual eIFU if required for the Australian market.
• Include a prominent statement on packaging: “Electronic Instructions for Use – Paper copy available on request.”
• Monitor user feedback and access statistics to ensure usability.
• Coordinate with Notified Bodies (if applicable) for conformity assessment updates.

Non-compliance with eIFU conditions may lead to enforcement actions, including product suspension or cancellation from the ARTG. Sponsors should consult the full TGA guidance and consider legal/regulatory advice for implementation. This guidance was last updated on 22 September 2025. https://www.tga.gov.au/resources/guidance/supplying-electronic-instructions-use-eifu-medical-devices