Supplying Electronic Instructions for Use (eIFU) for Medical Devices – TGA Guidance

Eligible Devices

Electronic IFU 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 users)

These categories align with devices where users are trained professionals and paper copies are less critical for routine use.

Key Conditions for eIFU

• Risk management: Sponsor must document in risk management file how eIFU does not increase risk and maintains safe use.
• Accessibility and reliability:
  • eIFU must be available online for at least 2 years after last device is placed on market (or 15 years for implants).
  • Reliable, continuous access (minimal downtime) with backup provisions.
• Security and integrity:
  • Protected against unauthorised access or alteration.
  • Use secure authentication and encryption where appropriate.
• User support:
  • Provide paper copy free of charge within 7 days upon request.
  • Include clear instructions on accessing eIFU and requesting paper version.
• Labelling requirements:
  • Device and packaging must indicate eIFU is provided electronically.
  • Include website address, access instructions, and statement on right to paper copy.
  • Symbol IEC 60417-6140 may be used to indicate eIFU.
• Language: eIFU must be in English; additional languages allowed.

Implementation Steps

• Update risk management documentation to justify eIFU.
• Develop and validate eIFU delivery system (website/platform).
• Revise labelling and packaging to meet eIFU notification requirements.
• Ensure ARTG entry reflects eIFU provision (if variation needed).
• Train distributors and users on eIFU access and paper request process.

Post-Market Obligations

• Monitor performance of eIFU system (access logs, request rates, complaints).
• Report any eIFU-related incidents or failures as adverse events.
• Maintain records of paper copy requests and fulfilment.
• Update eIFU promptly for any changes requiring labelling update.

Detailed eligibility criteria, risk assessment considerations, labelling examples, website requirements, transition arrangements, and compliance checklists are outlined in the TGA guidance on supplying electronic instructions for use (eIFU) for medical devices. Source: Supplying electronic instructions for use (eIFU) for medical devices - TGA

This framework balances environmental benefits of reduced paper use with patient and user safety requirements for high-risk medical devices in Australia.