<o:p> </o:p>I am seeking for clarification regarding applicability of TGA Guidance- Electronic Instructions for Use – eIFU, Version 1.0, August 2018.<o:p></o:p>
<o:p> </o:p>According to guidance, the provision of eIFU instead of paper IFU is limited to those devices intended for use by professional users, and not for supply to<o:p></o:p>
the general public. <o:p></o:p>
<o:p></o:p>Essential Principle 13.2(3) (Schedule 1, Part 2 of Therapeutic Goods (Medical Devices) Regulations 2002 ) allow information, where applicable, to be provided electronically rather than on paper for software-based medical devices. EP 13.2(3) is applicable to all software-based medical devices and is not limited to those intended for use by professional users. All software-based medical devices shall comply with the applicable clause of EP13 and EP13.B (Schedule 1, Part 2 of Therapeutic Goods (Medical Devices) Regulations 2002).<o:p></o:p>
<o:p> </o:p>Does a software-based medical devices, intended for general public, where the instructions for use are provided electronically rather than on paper (in accordance with Essential Principle 13.2(3)), need to comply with the relevant requirements of TGA Guidance- Electronic Instructions for Use – eIFU, Version 1.0, August 2018 further to EP13 and EP13.B?<o:p></o:p>
It is important to distinguish the clauses referenced in clause 13.2. EP 13.2 (3) is made in relation to subregulation 10.2(1) or clause 13.3. The clause defining information to be included in the IFU on the other hand is clause 13.4 "Instructions for Use". In this case, EP 13.2 (4) should be used to determine whether the IFU can be supplied in electronic format. EP 13.2 (4) states:
If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information under clause 13.4, the information must be provided in printed documents or other appropriate media.
From this statement, we can determine that the provision of eIFU with software-based medical device should follow TGA guidance (Electronic Instructions for Use - eIFU, Version 1.0, August 2018) to determine appropriate media. We can then reach the conclusion made in your second sentence - providing the IFU in only electronic format is not sufficient if the software-based medical device is intended for the general public.
I should also add that even if you want to supply the IFU in the software itself to comply with EP 13.2 (1) in relation to the IFU, the TGA guidance includes in the definition of eIFU "instructions displayed in electronic form: by the device ("help" systems, or graphical user interface (GUI)-based dialogues)", so I believe you are still beholden to the need for a professional user base to only provide the IFU in electronic format.
------------------------------Ian Boland, RACRegulatory Affairs SpecialistNJUnited States------------------------------
Thanks Ian for the detailed response.
Based on your interpretation, a SaMD where the IFU is provided in the software itsel ,still requires the provision of a paper IFU if the device is not intended or professional users. How do you do that with an App or any other device made available online?
------------------------------Ian Boland, RACRegulatory Affairs SpecialistNJUnited StatesOriginal Message:Sent: 19-Nov-2023 22:23From: Anonymous MemberSubject: eIFU SaMD - AustraliaThis message was posted by a user wishing to remain anonymous
Although not attractive from a marketability perspective, one option would be to have a more restrictive distribution method. As an example, if users were required to purchase an activation code mailed to them with the printed IFU, this would likely satisfy the requirement. I don't personally have much experience with this particular type of product though, so I'm not familiar with how existing SaMD applications with users in the general public handle this requirement.
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