Instructions For Use for Medical Devices

Closed 4 Jun 2024

Opened 15 Apr 2024

Feedback updated 30 Aug 2024

We asked

We undertook a public consultation related to instructions for use (IFU) for medical devices. We asked for your feedback on how IFU are provided and whether these should be made available in more flexible formats.

The consultation was hosted on the TGA Consultation Hub and was open for feedback from 15 April 2024 to 4 June 2024. Below is a summary of feedback received for the consultation paper. 

You said

One hundred and eight (108) responses were received from stakeholders including State and Territory health entities, health professionals, healthcare peak bodies, healthcare institutes, regulatory affairs consultants, consumers, and consumers peak bodies with most responses from medical device manufacturers and sponsors.

The feedback overall indicated support to change the requirements for providing IFU for medical devices, including allowing electronic instructions for use (eIFU) to be provided for a greater range of medical devices used by both professionals and consumers.

Responses from medical device manufacturers and sponsors noted that a shift towards eIFU will be cost effective for manufacturers, the instructions can be updated easily, additional information like safety concerns, recall, healthcare professional recommendations can be added instantly, and information can be provided in multiple languages.

Responses from medical device consumers, consumer peak bodies, health professionals, hospitals and hospitals peak bodies resonate with overall feedback that the requirements for IFU should move towards eIFU.

Responses noted that eIFU offers significant advantages for consumers and health professionals – it is convenient given almost everyone has access to a phone or computer, and allows flexibility in terms of language, font size, and supports environmental sustainability.

Responses also noted that if changing the requirements, careful consideration of accessibility, security, and regulatory compliance is essential to ensure that eIFU meet the needs of all users while maintaining safety standards.  

There was support for consumers who do not have internet access or are not confident using digital information to be able to access a paper version of the IFU free of charge and within a certain timeframe.

Specific devices that should be provided with an eIFU

There were mixed responses on specific types of medical devices that should be provided with an eIFU. Some suggested that the option for eIFU should be encouraged with all medical devices whereas others suggested that manufacturers should be allowed to determine if an eIFU is appropriate for their product based on factors such as intended users, risk and benefit analysis and probability of device misuse.

There are certain situations where a paper version may be more beneficial over an electronic version including emergency situations (e.g., pacemakers), accessibility issues for vulnerable populations (e.g. elderly), remote or low-resource settings (e.g. war zones), high safety risks, and unreliable technological environments (e.g. inconsistent internet/cellular communication or electricity service). Traditional printed IFUs remain a critical safety component for these scenarios, ensuring users can access information without relying on technology.

Availability of eIFU

Most respondents suggested that the eIFU should be made available until a few years after the expected lifecycle of the product as consumers tend to use a medical device even after the expiry date. There were other suggestions that the duration should be determined based on a number of factors such as type of the device, patient safety, intended user (health professional or consumer), number of updates made, the impact of change to end users, device complexity and manufacturing policies.

Accessibility and storage of eIFU

Most respondents suggested the eIFU to be made available through a manufacturer’s website and consumers be provided with a searchable link or QR code on packaging to access it without having to register or sign-up to their website. There should also be an option to download the eIFU in common and searchable formats like Word or PDF for the purposes of printing.

Most medical device consumers and health professionals stated that they will prefer the TGA website or the Australian UDI database to be the central source for accessing eIFU.

Manufacturers’ requirements for supply of eIFU

Most respondents agreed with the proposed manufacturer’s requirements by the TGA for supply of eIFU with additional suggestions such as multilingual support, accessibility support for disabled users, establishing a process for revision control, notification to all users if information is updated, and removing unnecessary sign-in and password protection to access manufacturer’s website. Those who disagreed had concerns about the need to maintain eIFUs on both the manufacturer’s website and the UDI database.

We did

We have reviewed the feedback received for this consultation. All feedback on the proposals will be provided to the Minister and the Government for their consideration. We will inform stakeholders on the outcomes of the Government’s consideration, including any approval to  progress adopting changes to the requirements for IFUs.

Published responses

View submitted responses where consent has been given to publish the response.

Overview

The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe.

The Therapeutic Goods Act 1989 and associated supporting legislation set out the regulatory requirements for medical devices. This includes the information to be provided with a medical device through product label and Instructions for Use (IFU) and the format it must be provided in. The IFU is the information provided by the manufacturer for the intended user detailing how the device can be used safely for its intended purpose. For implanted medical devices, further information is available to patients in the form of patient information leaflets (PIL) and patient implant cards (PIC).

We are seeking feedback on how IFU are provided, and whether electronic IFU (eIFU) should be made available in more flexible format.

Why your views matter

The feedback received through this consultation will contribute towards further strengthening of the regulatory framework related to IFU for medical devices and the format in which it is made available. Please download and read the consultation paper available as attachment at the bottom of this page for information on the proposals.

The survey:

The proposals are listed in a questionnaire format for your feedback. Click on the link ‘Consultation Questions’ available at the bottom of this page to provide feedback. On the ‘Introduction’ page, there are questions seeking information about yourself and a mandatory question regarding consent to publish your feedback. After you finish responding to questions on this page, click on ‘Continue’ button to view questions on the next page. Respond to the questions on the page ‘Instructions for Use for Medical Devices’ and click on ‘Continue’ button to move to the next page ‘Submit Document’. If you wish to submit your response through a document or attach supporting document, click on the ‘Choose File’ button on the ‘Submit Document’ page. Click ‘Continue’ button to submit your response through the ‘Almost Done…’ page. Your response will not be submitted until you click on ‘Submit Response’ button on the ‘Almost done…’ page.

Average time to complete the survey is 10 minutes.

Please contact the TGA by email at: devicereforms@tga.gov.au if you have any questions or concerns related to this consultation.

What happens next

Submissions will be reviewed by the TGA. Feedback collated during this consultation process will inform policy decisions on requirements for Instructions for Use (IFU) for medical devices and will be provided to the Government for consideration.

Audiences

  • Anyone from any background

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Legislation
  • Regulatory policy
  • Preventative health
  • Strategic Policy
  • Policy Development