The Australian Therapeutic Goods Administration (TGA) recently published the results of its public consultation on instructions for use of medical devices. This consultation invited input from instances such as medical device manufacturers (MDMs), regulatory and quality assurance (QA) professionals, and healthcare practitioners regarding the questions on how IFU are provided and whether IFU should be made available in more flexible formats (such as electronic Instructions for Use or eIFU). The published feedback from the consultation is available here
As a Swiss-based provider of eIFU services with a global customer base, dokspot welcomes the TGA's initiative and has thoroughly reviewed the feedback. This blog aims to contribute to the ongoing dialogue by examining critical aspects raised during the consultation.
Observations on the Consultation Approach One key observation is that the consultation's questions were directed at a broad audience without clearly defining foundational premises concerning the role of Instructions for Use (IFU) for medical devices. These premises include:
Legal Responsibility : Medical device manufacturers bear the legal responsibility for the device and for ensuring that Instructions for Use (whether electronic or paper) are provided.Critical Function of IFUs : IFUs are integral to the safe and effective use of medical devices.Regulatory Compliance : The combination of the medical device and its accompanying IFU is subject to stringent regulations and standards.Discussions that overlook these fundamental principles fail to address the core complexities of implementing eIFU systems effectively. As a result, many contributions to the consultation may offer limited actionable insights.
Key Questions on the Future of eIFU A pivotal issue is whether eIFUs should be accessible exclusively via a manufacturer’s website or whether additional platforms, managed by regulatory agencies or professional associations, should also host them. Some jurisdictions are exploring state-managed systems requiring MDMs to publish eIFUs both on government-run platforms and their own websites.
However, creating state-controlled repositories would not absolve manufacturers of their regulatory responsibilities. Furthermore, this dual-publication requirement could impose significant administrative burdens, particularly for manufacturers operating in international and multilingual markets.
Additional Questions to Address We believe the consultation's scope was overly broad, leading to feedback that inadequately considered the complexities of implementing eIFU systems. To address these complexities more effectively, we propose the following questions:
Compliance : How can manufacturers ensure compliance with global regulatory standards with eIFU?Accessibility : Are eIFUs as accessible and user-friendly as traditional paper IFUs for all users?Global Standards : Can eIFU-hosting websites meet the regulatory requirements of diverse international markets?Operational Efficiency : How does transitioning to eIFUs streamline manufacturers' internal workflows compared to paper-based processes?Sustainability : Does adopting eIFUs support environmental goals by reducing paper usage?Regulatory Benefits : Can eIFU systems simplify oversight and enforcement for regulatory authorities?Broader Implications for the Medical Device Industry While the TGA’s consultation briefly addressed some of these issues, a deeper examination is essential. eIFU systems have significant implications for manufacturers, influencing quality assurance processes, regulatory compliance, and operational efficiency.
Addressing these critical questions in future consultations will provide more comprehensive insights. This approach will help ensure that eIFU systems deliver clear benefits to all stakeholders—manufacturers, regulators, healthcare providers, and patients alike.
dokspot is a leading provider of electronic Instructions for Use (eIFU) solutions, catering to the medical and in vitro diagnostic industries. With a proven track record, dokspot has successfully assisted medical device manufacturers in implementing regulatory-compliant eIFU systems powered by its cutting-edge eIFU services.
The company excels in navigating complex international eIFU regulations, ensuring quality assurance, and structuring data for compliant eIFU delivery. dokspot also specializes in seamless API integration with manufacturers' lifecycle management systems, streamlining processes for enhanced efficiency.
Headquartered in Zurich, Switzerland, dokspot serves a diverse clientele—from small enterprises to global manufacturers—delivering reliable eIFU solutions worldwide.
