Instructions For Use for Medical Devices

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. 

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 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.