Instructions For Use for Medical Devices

The Essential Principles in the Regulations are already flexible enough to allow manufacturers to provide IFU in a format which is suitable to their device, including electronic IFU (eIFU), regardless of who the user of that device is (consumer vs healthcare professional).

Essential Principle 13.2(4) already states that:
"If it is not practicable to comply with subclause (1) or (2) in relation to the provision of the information required under clause 13.4, the information must be provided in a printed document or using other appropriate media."

There is currently no restriction in the Essential Principles, or elsewhere in the Regulations, limiting eIFU to only be provided to healthcare professionals for specific device types. That assertion is only contained within the TGA guidance document (form 2018). As such, TGA could simply update their guidance document to indicate eIFU can be provided with any medical device, so long as it is not practicable to provide on the device itself (EP 13.2(1)) or on the device packaging (EP 13.2(2)).

As explained in Question 1 above, there is currently no restriction in the current Regulations on the type of professional users that eIFU is suitable for.
This assessment should continue to be made on a case-by-case basis, and supported by suitable justification from the manufacturer of the device.

As explained in Question 1 above, there is currently no restriction in the current Regulations for providing eIFU where users of a device are consumers.
This assessment should continue to be made on a case-by-case basis, and supported by suitable justification from the manufacturer of the device.

For example, devices which are software in the form of a smartphone app used by consumers (such as an app used to control cochlear implant sound processors). For these types of devices, it would not be practicable to provide the IFU in paper format. In fact, if the IFU is provided in electronic form within the app itself, then the manufacturer would have complied with EP13.2(1) in providing the IFU (because it is provided in the device itself).

Any type of medical device software, regardless of whether the user is a healthcare professional or consumer.

Any other device where the manufacturer deems it impracticable to provide paper IFU in the packaging of the device. Such as:
- where the IFU is very large or contains multiple volumes of information
- where the instructions are required at a later date, such as for performing MRI on patients with a particular implant
- devices that contain software which is updated regularly. This would allow users to always access the current up-to-date version of the IFU without relying on old paper IFU that could no longer be safe if followed.

As is currently required by the Regulations, the manufacturer should always be required to justify the method of providing the IFU for their device. There should no limitation on any specific types of devices, but this should be determined on a case-by-case basis.

Obviously some devices do not lend themselves to accessing eIFU, and I would not expect manufacturers to be able to justify providing eIFU for those devices, but there shouldn't be a specific restriction added to the Regulations. For example, condoms or first aid devices are unlikley to be suitable for eIFU to be provided.

It is reasonable to expect eIFU to be available to the user for at least the same amount of time as paper IFU would be available.

It depends on the device and user. In most cases eIFU will be made available through a website of some kind. But it may be best for eIFU to be provided on some other media, such as a USB storage device, or through a mobile phone app.

I would agree with most of the above requirements.

However, I don't think it will always be appropriate (or even possible) to provide paper versions of the eIFU at the request of the consumer.

I also disagree that eIFU should be available via a database maintained by the TGA. Manufacturers will make the IFU available on their own website. If TGA have their own database containing the same eIFU, then this just increases the chance of a misalignment between versions of IFU available, and could lead to a user referring to a version which is out of date. It would be an unnecessary duplication of effort.