Instructions for Use (IFU) for Medical and in vitro Diagnostic Devices Device manufacturers are required to provide Instructions for Use (IFU) to ensure the safe use of their products. These instructions have commonly been provided in printed format together with the device. In accordance with regulations (e.g., EU Regulation 2021/2226 and FDA Blue Book), device instructions can be provided in electronic format, for example via a website. This process is called electronic Instructions for Use (eIFUs).
Benefits of Electronic IFUs Electronic instructions for medical and in vitro diagnostic devices make sense for two reasons:
Meeting Expectations with eIFUs Today customers expect instructions to be provided digitally via the internet. Forward-looking manufacturers can leverage digital instructions to better meet customer expectations. Providing electronic instructions may allow customers to gain a better understanding of the product and ensures that they always have the instructions at hand. This can lead to improved safety and outcome of the device application.
Regulatory Considerations for eIFU Replacing printed instructions with electronic instructions is possible for certain groups of devices. A common regulatory requirement for electronic instructions is that the device is exclusively used by professionals.
Cost Savings and Operational Efficiency Electronic instructions may also lead to reduced product cost and simplified operational and administrative processes. The cost of the printed instructions and the operational resources required to add these paper instructions to the product can be saved by using electronic instructions. On an administrative level, the cost of sourcing, stocking, and replenishing the instruction documents can be eliminated.
Challenges and Hesitations in eIFU Adoption Most manufacturers today are exploring solutions for electronic instructions. However, many are hesitant to go completely digital until a common and established process is in place. Some device manufacturers are starting to use the concept of electronic instructions not to duplicate the paper instructions but to complement these through enhanced content, such as video or interactive instructions.
The Future of eIFUs in Medical and in vitro Diagnostic Devices Tomorrow's best-in-class devices will be accompanied by electronic instructions, which will allow customers improved understanding of the product and enable manufacturers to run improved operations. Already today, a new wave of manufacturers in the marketplace is exploring electronic instructions as a way of gaining a competitive advantage.
Preparing a Strategy for eIFUs Whether the objective is cost reduction, improved safety, or better communication, device manufacturers should have a strategy for electronic instructions in place to maintain competitiveness and differentiation.
