In a period characterized by rapid digital transformation and technological advancements, the adoption of Electronic Instructions for Use (e-IFU) stands out as a critical evolution in the medical device sector. e-IFU represents a significant leap towards enhanced efficiency, sustainability, and improved user experience. This position paper explores the integration of e-IFU, addressing the regulatory challenges and potential benefits as the industry moves towards digital solutions.
This paper offers an overview of the Electronic Instructions for Use (e-IFU), highlighting the need for regulatory enhancement and industry collaboration. Representing the Medical Technology industry in the Middle East & Africa Region, Mecomed's position is that electronic Instructions for Use (e-IFU) should become the default form for professional-use medical devices across the Middle East Africa region, with paper copies available free of charge upon request. Mecomed also supports, in alignment with international best practices, a phased and risk-based approach to eventually in the future extending e-IFU access to lay users and IVDs, ensuring accessibility and safety."
Globally, there is a clear and growing acceptance of electronic Instructions for Use (e-IFU) by both regulatory authorities and the medical device industry. e-IFU has been authorized for professional use across numerous countries, including the European Union (EU)8 Australia, the United States, Canada, Saudi Arabia, Bahrain, Turkey, the United Kingdom, Japan, Singapore, South Korea, India, Malaysia, Chinese Taipei, Thailand, Vietnam, New Zealand and Brazil. Furthermore, acceptance continues to expand with e-IFU for lay users now permitted in India, Thailand, Vietnam and South Korea.
This global acceptance highlights the crucial role e-IFU plays in ensuring that healthcare professionals, as well as lay users, where permitted, have instant access to the most up-to-date instructions. By delivering timely and accurate information e-IFU enhances safety and efficacy while also helping to reduce waste and environmental footprint.