EUDAMED and eIFU: Direct Integration with UDI Data

Why Our Customers Use the mytracekey Software as Their eIFU Solution

Electronic Instructions for Use (eIFUs) for medical devices have only become a true alternative to traditional paper IFUs since 2025. Today, manufacturers can transition all products, including accessories, to fully electronic instructions for use. This applies to all medical devices intended exclusively for professional users and not for laypersons. To support medical device manufacturers, tracekey solutions offers a dedicated eIFU software solution. Since EUDAMED requires a direct connection between eIFUs and UDI data, the eIFU solution is integrated into our UDI registration software for EUDAMED.

In this article, we introduce several typical tracekey eIFU customers and demonstrate the advantages that medical device manufacturers gain from using the tracekey eIFU software.

eIFU and UDI Software Go Hand in Hand

For one of our customers, the topic of UDI registration was initially the reason for reaching out to us. They were looking for an efficient way to handle their upcoming UDI registration in EUDAMED. The mytracekey UDI Manager was already being considered as a potential solution, but no final decision had been made.

The company had been following our newsletters for some time. That is how they became aware of tracekey’s new eIFU solution through one of our communications.

During discussions with our sales team, it became clear that both topics were closely connected. Instead of treating eIFU management and UDI management as separate projects, the company chose a combined approach. A key factor in this decision was the ability to centrally manage regulatory product data and handle both EUDAMED registration and the provision of electronic instructions for use through a single integrated platform, the mytracekey UDI Manager.

During the discussions, it also came up that the company planned to market its products in Australia in the future. The ability to support not only EUDAMED requirements but also AusUDID requirements through the same UDI solution further strengthened the decision. Rather than implementing multiple standalone systems, the company opted for a scalable platform from tracekey. A platform that supports current regulatory requirements and future market expansion plans.

Extending the Value of UDI Registration Software Through the eIFU Module

Many companies initially implement the mytracekey UDI Manager to manage their UDI data and meet regulatory registration requirements. One of our existing customers followed this path and had already been using our UDI solution for an extended period.

After learning about our new eIFU solution on our website, the company contacted us again to explore its possibilities.

During a joint demo, it quickly became apparent that the existing UDI database could also be used for managing electronic instructions for use. Instead of introducing another standalone solution, the medical technology company decided to integrate its eIFU management into the existing tracekey environment.

Although the company had already made its instructions for use available online, its existing solution did not meet all regulatory requirements for eIFUs. By extending the UDI Manager with eIFU functionality, the customer was able to centralize the management of product information. Now they can handle both UDI data and electronic instructions for use within a single platform.

From an eIFU Solution to Centralized Product Data Management

A medical device manufacturer became aware of tracekey while searching for a suitable eIFU provider. Through online research, the company discovered our website and quickly realized that the solution supports not only the provision of electronic instructions for use, but also the management of regulatory product data.

Further discussions revealed that the customer had already successfully registered its UDI data in EUDAMED. However, the company was looking for a way to consolidate both eIFU management and UDI data maintenance within a single centralized system. Consequently, the customer decided to implement the mytracekey UDI Manager alongside the eIFU solution for future UDI data management.

Thanks to the Machine-to-Machine (M2M) integration, the UDI data already stored in EUDAMED could be efficiently transferred into the mytracekey platform. This provided the company with a centralized data foundation for both processes and significantly reduced administrative effort.

Functions such as integrated version management for regulatory changes and automatic assignment of language versions proved particularly valuable. These features make the provision and maintenance of electronic instructions for use even easier. What initially started as a search for an eIFU solution evolved into a comprehensive approach for managing UDI data and eIFUs on a shared platform.