Making the switch to electronic instructions for use (eIFU) has a host of benefits for manufacturers and patients alike. This guide introduces some of the most important steps for manufacturers making the eIFU transition.
The case for eIFUs
Manufacturers can boost efficiency and security and cut down costs by hosting IFU online. By removing paper leaflets, manufacturers can reduce costs, mitigate environmental impact and pack products in smaller boxes. eIFU are far easier to modify and update, reducing the chance of IFU-related product recall.
Transition guide
1. Understand regulatory requirements. "The first exercise is, for all your products, determining which countries allow eIFUs and what the different requirements are," explains Conny Van Loon, senior consultant at Qarad.
2. Notify the NB. The transition must be conducted in line with the change control procedure, including an in-depth risk analysis.
3. Update IFU procedures. Transitioning will impact labelling, promotional, packaging, logistics and qualification procedures.
4. Inform customers. Information on where to find eIFU must appear on the device or its packaging.
An expert partner
IFUcare is built around experts in eIFU backed by Qarad's three decades of experience. The IFUcare "test site" demonstrates the platform's user-friendliness. "We know exactly which conditions are needed in different countries," explains Van Loon. "Outsource to a supplier that is certified – not only ISO 13485 but also ISO 27001 certified."
