Digital Labeling and eIFU Enhance Customer Experience, Facilitate Compliance, and Improve Operational Efficiencies and Agility

Description: A harmonized and standardized approach to digital labeling fosters global access to medical technology, as it addresses logistical challenges caused by localization efforts needed to comply with the multitude of different regulations across different countries today.

Labels have become overcrowded with data not directly related to the safety of medical devices and while there is an agreement that core information on the identification of a device and its handling is needed, additional information, especially information from country-specific regulations, could be available to users via a digital label. Electronic IFUs and digital labels can provide this additional information, in a timely, effective, and fit for the digital age manner.

Electronic instructions for use (IFU) can benefit patients, physicians, caregivers, and manufacturers, by increasing the availability, utility, interactivity, and accessibility of IFU. In addition, supplying electronic IFU may have environmental benefits, including reduced ethylene oxide emissions, reduced paper usage, and a reduced carbon footprint.

Key Takeaways:

• Review current state mapping of e-IFU acceptance


• Review examples of current challenges and solutions


• Potential concepts to provide a holistic approach to product information


• Role in promoting sustainability


• Forging strong partnerships across industry and other stakeholders for wider global acceptance and adoption of e-IFU and digital labeling