At the end of 2024, the European Commission (EC) published guidelines on data exchange with EUDAMED. They describe the three upload variants: Manual upload, bulk upload and a machine-to-machine (M2M) connection. For this purpose, their advantages and disadvantages are presented. The commission also provides an overview of the conditions under which each upload variant is worthwhile and which is not. The focus here is on the number of UDIs to be reported and the frequency of use of EUDAMED.

While the guidelines can provide a good overview, we at tracekey do not agree with every point. Therefore, in this article we want to take a closer look at some of the statements from the European Commission’s guidelines and compare them with the functions and requirements of our UDI Manager.

The new EUDAMED guidelines

The European Commission’s guidelines are intended as a support for the competent authorities, notified bodies and economic operators. Economic operators are defined as manufacturers, authorized representatives, importers and manufacturers of system and procedure packs. The document explains how data can be efficiently uploaded to EUDAMED.

It describes the three input methods as follows:

1. User Interface (UI): Here, data is entered manually via EUDAMED’s own user interface. All that is required is a computer with Internet access and a browser.
2. XML bulk upload: This semi-automated method allows users to upload data in the form of an XML file. Users must validate the file in advance to ensure that it complies with the EUDAMED format. Although the creation of these files can be automated, the upload process remains manual.
3. Machine-to-Machine data exchange (M2M): Data can be exchanged directly between an external system and EUDAMED’s backend system using this fully automated method. It transfers data in XML format without human intervention. The guideline describes that this method can be costly due to various technical and operational circumstances.

Furthermore, a flowchart shows from how many UDIs it is worthwhile for economic operators to use which input method. Accordingly, it makes sense to use the EUDAMED user interface for up to 99 UDIs. From 100 to 1000 UDIs, according to the European Commission, the XML bulk upload is suitable if you have to deal with EUDAMED on a weekly or monthly basis. For more than 1000 UDIs and a high frequency of use, the M2M connection is the ideal method. The directive points out that a third-party system, i.e. external software, is required here.

We at tracekey see this classification somewhat differently.

Advantages of the EUDAMED M2M connection

First of all, we want to look at the advantages of using EUDAMED with an M2M interface. We were able to identify three points that an M2M connection has that make it stand out from the other two methods:

• Automated data exchange: It enables the automatic exchange of data between your internal systems and EUDAMED. The need for manual data entry is reduced, minimizing human error.
• Efficiency and speed: Automation eliminates several work steps. It speeds up the transmission and updating of information considerably. It also makes it easier for users to ensure that the data is always up-to-date and correct.
• Compliance: Using the M2M connection, you can ensure that complete documentation on data entries is available in EUDAMED. An audit trail and correct versioning of the data are also included.

Other points such as the collection of data in a single, secure location and pre-validation are also among the benefits of the EUDAMED M2M connection. However, many of the benefits are not limited to the M2M connection. If you use software such as the mytracekey UDI Manager, you can also benefit from an audit trail or data pre-validation for XML bulk uploads.

Guideline vs. Reality

As mentioned at the beginning, the EC makes some statements that we would like to object to. For example, the flowchart specifies a division into 1-99, 100-1000, and over 1000 UDIs. However, with the low price of our UDI Manager, we are convinced that the XML bulk upload is already worthwhile from 15-20 UDIs. It is also assumed that an M2M solution can only be fully exploited if manufacturers use the tool on a daily basis. This assumption is also invalidated by the modularized offering of our UDI Manager. The M2M interface is already available in mytracekey for an insignificant additional charge.

It is not only the flowchart of the EC guideline that depicts a distorted picture of reality, but also the requirements listed. As the number of UDIs increases, the upload variants generally become more complicated. Thus, EUDAMED’s UI has the lowest requirements, followed by the XML upload. However, the bulk upload is presented as far more complicated than it actually is. While the guideline assumes that the creation of an XML file is so complex that an IT team is required, the practice is fundamentally different. Thanks to a detailed user manual and an intuitive UI, familiarizing yourself with our UDI Manager and uploading via XML file is just as simple as the EUDAMED manual upload.

The biggest discrepancy between theory and practice is in the guideline for the M2M connection. According to the EC, an external system is required for this. They are right about this, but there is also talk of specific hardware that has to be set up and maintained on site by the manufacturer. Instead, with our cloud-based UDI manager, including M2M connection, you have the same requirements as with the EUDAMED interface or the XML bulk upload: a computer with an Internet connection.

Why should I opt for an M2M connection?

It is also added that this option is the most complex and costly of the three. Furthermore, it is advised to use an M2M connection only under the following conditions:

1. The Actor that needs to exchange data with EUDAMED has a database outside EUDAMED for these data.
2. The amount of data to be uploaded is too important for being entered manually (would be too burdensome and take too long).
3. There will be frequent exchanges of information with EUDAMED.
4. The cost of manual input outweighs the cost of automation.
5. The Actor has enough available and necessary resources, competence, and infrastructure for implementation and maintenance.

At this point, we would like to pick up where we left off. We are convinced that thanks to our UDI Manager with M2M connection, uploading to EUDAMED will become less complicated while remaining cost-effective. In addition:

1. This is provided by us. Thanks to years of expertise in the pharmaceutical industry, with which we permanently and securely store billions of codes and product histories and exchange them with authorities, the exchange between databases is no problem for us.
2. The UDI Manager is particularly worthwhile due to the high volume of data. It saves time and money.
3. The exchange is standardized and secure with the UDI Manager. In addition, the UDI data is pre-validated, which avoids errors and the need for corrections.
4. Thanks to our fair pricing model, costs are already reduced from a small number of UDIs compared to manual entry.
5. We take care of maintenance and infrastructure. The resources and skills required are kept within reasonable limits thanks to our user-friendly interface and pricing structure.

Conclusion

The EU Commission is right on many points in its directive. However, many assessments are different when you know that there is a suitable, cost-effective tool on the market that automates many process steps, brings numerous advantages for quality management and represents an efficient, easy-to-use option for UDI management overall.

If you would like to find out more, take a look at our UDI Manager online or arrange a no-obligation demo with us.