Response 706245133

Back to Response listing

Introduction

1. What is your name?

Name
Gary Burgess

3. What is your organisation?

Organisation
Hill Valley Regulatory Consulting

4. Which industry component(s) do you represent? You may tick as many boxes as apply to you.

Please select all that apply
Checkbox: Unticked Manufacturer (Australian)
Checkbox: Unticked Manufacturer (Overseas)
Checkbox: Unticked Sponsor
Checkbox: Unticked Consumer
Checkbox: Unticked Health professional or health practitioner
Checkbox: Ticked Regulatory affairs consultant
Checkbox: Unticked Educational Institution
Checkbox: Unticked Medical device industry organisation or peak body
Checkbox: Unticked Consumer peak body
Checkbox: Unticked Health professional or health practitioner organisation or peak body
Checkbox: Unticked Hospital or other health organisation or peak body
Checkbox: Unticked Other (please specify in the box below)

Instructions for Use for Medical Devices

1. Do the current requirements for providing IFU for medical devices need to change?

Please select one item
Radio button: Unticked Yes (explain in the box below)
Radio button: Ticked No (explain in the box below)
Explain why?
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)).

2. Should eIFU be allowed for a greater range of medical devices for professional users?

Please select one item
Radio button: Ticked Yes (explain in the box below)
Radio button: Unticked No (explain in the box below)
Explain why?
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.

3. Should eIFU be available for consumer medical devices?

Please select one item
Radio button: Ticked Yes (explain in the box below)
Radio button: Unticked No (explain in the box below)
Explain why?
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).

4. Are there specific types of medical devices that should be provided with an eIFU?

Please select one item
Radio button: Ticked Yes (explain in the box below)
Radio button: Unticked No (explain in the box below)
Explain why?
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.

5. Are there specific types of medical devices that should NOT be provided with an eIFU?

Please select one item
Radio button: Unticked Yes (explain in the box below)
Radio button: Ticked No (explain in the box below)
Explain why?
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.

6. If an eIFU is provided for a medical device, how long should it be accessible for?

eIFU should remain accessible for:
The expected lifetime of the last device supplied, or for as long as paper IFU would need to be retained within the manufacturer's QMS.
Explain why?
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.

7. How do you think eIFU should be stored and made available?

Provide your response below.
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.

8. Do you agree with the proposed requirements for supply of eIFU that manufacturers must meet?

Please select one item
Radio button: Unticked Yes (explain in the box below)
Radio button: Ticked No (explain in the box below)
Explain why?
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.

9. Are there any additional requirements for supply of eIFU that manufacturers must meet?

Please select one item
Radio button: Unticked Yes (explain in the box below)
Radio button: Ticked No (explain in the box below)