Making the switch to electronic instructions for use (eIFU) has a host of benefits for manufacturers and patients alike. First, though, in vitro diagnostics (IVD) and medical device manufacturers must handle several significant procedural changes and ensure they remain compliant with international regulations. This guide introduces some of the most important steps for manufacturers making the eIFU transition.
The case for eIFUs
The great news for manufacturers is that they can boost efficiency and security and cut down costs by hosting instructions for use (IFU) online rather than printing them. By removing the need for bulky paper leaflets, manufacturers can reduce paper and printing costs, mitigate their environmental impact and pack products in smaller boxes. Operationally, this relieves a source of packing error and can streamline supply change by minimising market-specific packaging.
eIFU are far easier to modify and update than the paper alternative, reducing the chance of IFU-related product recall. For patients, eIFUs are also more accessible, offering the possibility to include high-resolution images and videos, alternative colours and font sizes, different language translations and facilitating links to supplementary external resources.
Transition guide
The transition from paper IFU to eIFU will affect many fundamental processes in the manufacturing system and entails a significant change in quality management. Notified bodies (NBs) will conduct a rigorous validation of new systems. In addition to the eIFU platform itself, this validation stretches beyond to take in the entire manufacturing process. Ensuring you remain compliant is essential.
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, creator of IFUcare. “That’s the role of the quality assurance or regulatory department.” The types of devices which allow eIFU vary from country to country. In the EU, this is regulated by MEDDEV guidance, IVDR regulations and a range of medical device-specific laws and directives. “If you have different products in scope and you’re selling in different parts of the world, that can be very complex,” adds Van Loon.
2. Notify the NB. The transition process must be conducted in line with the business’s change control procedure, including an in-depth, verified risk analysis. Manufacturers may need to prepare for audit by the NB. The NB will verify that the eIFU implementation, including the online platform, meets all regulatory requirements. For example, one requirement states that customers must be able to obtain paper IFU on request; manufacturers must prepare thoroughly to address these requirements to gain NB approval and unlock the benefits of eIFUs.
3. Update IFU procedures. Transitioning to eIFU will impact a range of elements of the labelling, promotional, packaging, logistics and qualification procedures. “The packaging and labelling will be most affected,” says Van Loon. As the move away from paper accelerates, medical products will take on a completely new look and feel; preparing for this now is a vital precursor to the eIFU transition.
The impact on technical documentation, post-marketing surveillance and suppliers should also be considered. “The supply chain and ERP system needs to be updated,” Van Loon explains. “The sterilisation process also needs to be revamped, because the weight of the packaging is less without an IFU.”
New procedures will be required for operation of the eIFU platform, including updating and testing procedures. While the burden of printing and handling requirements will become much lighter without paper IFU, employees should be trained to know how to validate, upload and update eIFU.
4. Inform customers. According to regulations, information on where to find eIFU must appear on the device or its packaging. The most effective method is to print a URL on the packaging. This information should also detail how to request a paper copy of IFU, for example by providing a phone number.
An expert partner
The key to a smooth and effective transition to eIFU is choosing the right partner. Outsourcing the transition removes the regulatory burden from manufacturers and means they can begin reaping the rewards of eIFU sooner.
IFUcare is built around experts in eIFU – backed by Qarad’s three decades of experience in regulatory affairs and quality systems – with a robust regulatory foundation. IFUcare’s change and audit documentation process prepares the manufacturer for NB review. And the IFUcare “test site” demonstrates the eIFU platform’s user-friendliness, something that can be drawn upon to speed up engagements and approvals with NBs.
“We know exactly which conditions are needed in different countries,” explains Van Loon. “Our labelling service already complies with all the conditions mentioned in the IVDR, MEDDEV and MD regulations already.”
“The platform is readily available and pre-validated. That’s very important, so you don’t have to do it all yourself and the focus can stay on your internal processes.”
The goal is to ensure that the right information gets to the user and the manufacturer remains compliant. Van Loon’s advice: “Outsource to a supplier that is certified – not only ISO 13485 but also ISO 27001 certified.”
