What is eIFU?
Electronic Instructions for Use (eIFU), sometimes called electronic IFU, refers to the digital representation of instructions, guidance, and information provided by manufacturers for the safe and effective use of medical devices. It is an alternative to the traditional paper-based format and is designed to meet regulatory requirements while offering enhanced accessibility and usability for healthcare professionals and other users.
Electronic Instructions for Use (eIFU) revolutionizes medical device instructions. As a digital alternative to paper-based formats, eIFU provides accessible, searchable information, faster updates, and compliance with regulations like FDA and EU MDR. With rigorous risk assessments, manufacturers ensure safety, usability, and data protection. eIFU’s transition requires effort, but benefits like real-time updates and improved usability outweigh costs. In a nutshell, eIFU empowers healthcare professionals, contributing to patient safety and quality care.
