The power of eIFU in a product recall process

Product recalls are a fact of life for Medical Device manufacturers – but they can also be a headache. Fortunately, the advent of electronic Instructions for Use (eIFUs) is helping to ease the pain.

Product recalls can be a challenging and costly endeavor for manufacturers. When they occur, the need to swiftly and effectively communicate important information to consumers, healthcare professionals, and other stakeholders is crucial.

In recent years, there has been a significant evolution in simplifying this process using electronic Instructions for Use (eIFU). These are the digital format of product instructions and safety information that can be easily accessed and distributed electronically. This technological advancement has revolutionized the way product recalls are managed, making the process quicker, more efficient, and more accessible for all parties involved.

The paper-based past

Traditionally, product instructions and safety information were provided in paper format, and included in the packaging of medical devices or in vitro diagnostic (IVD) products. However, this posed challenges during product recalls occurring due to incorrect information in these documents.

This could even happen in cases where a product worked perfectly. A recall may still be necessary due to incorrect or insufficient information in package inserts regarding cleaning or sterilization methods. These printed instructions are difficult to update, distribute and retrieve – particularly when a recall affects a wide range of products or requires immediate action.

How eIFUs can help

Electronic alternatives to paper – eIFUs – are providing an answer to these problems. They enjoy four key advantages that can ease the product recall process – or stop it from happening to begin with.

Firstly, eIFUs allow for real-time updates and revisions to instructions and safety information. Manufacturers can swiftly address any emerging issues and provide additional guidance as new information becomes available. This ensures that the most up-to-date and accurate instructions are readily accessible to all stakeholders involved in the recall, minimizing confusion and potential risks.

Secondly, the electronic format enables manufacturers to easily distribute the updated instructions and safety information to relevant parties via a few simple clicks. It eliminates the need for cumbersome and time-consuming physical distribution processes, reducing costs and allowing for rapid communication during critical recall situations. Even for unsold products in stock, the use of eIFU alleviates the burden of updating by eliminating the need for reprinting and manual replacement of paper leaflets within each individual box. This is particularly handy for sterile products; the costs and workload associated with resterilisation escalate every time a replacement occurs, exacerbating the challenges and complexities involved in the recall process.

Another significant advantage of eIFU is its accessibility. With the widespread use of digital devices like smartphones, tablets, and computers, eIFUs can be accessed anytime, anywhere. This accessibility is indispensable during product recalls when distributing information rapidly and accurately can help prevent further harm or misuse of affected products.

Furthermore, eIFUs can simplify the process of verifying whether individuals have received and reviewed updated instructions. The IFUcare platform does so by supporting a module that ensures users are seamlessly notified via automated email alerts whenever an IFU undergoes updates, ensuring timely access to the latest information. This capability is vital during recalls, as it helps ensure that users are aware of the recall and have taken the necessary actions to mitigate potential risks.

The advent of eIFUs has revolutionized the way product recalls are managed. By providing real-time updates, eIFUs play a critical role in making product recalls easier, faster, and more efficient for all parties involved. Working with an experienced partner like IFUcare could help medical manufacturers exploit the potential benefits sooner rather than later. Download the whitepaper on this page to find out more.

Software requirements for a compliant eIFU website development

This document contains an overview of software requirements for an eIFU website and how the Software Development Life Cycle (SDLC) can serve as a guide to create a compliant system.


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