The direct connection to EUDAMED, M2M, offers many advantages. Even if the setup is a little more complex at first, this is no problem with a competent and experienced software partner such as tracekey solutions. In this article, we explain the technical implementation and the basics of machine-to-machine (M2M) communication with EUDAMED.

M2M is an interface between the mytracekey UDI Manager software and EUDAMED. It enables the direct and automated exchange of information between the two systems and a fully automated upload process. Using the direct interface offers several advantages. It is more efficient, error-free, and scalable compared to manual data entry or uploading an XML file.

• Efficient: Data is transferred automatically, meaning quickly, securely, and accurately.
• Correct: With M2M, data is transferred directly from one system to another. Errors, as with manual transfer, cannot occur.
• Scalable: M2M is particularly worthwhile for large data volumes. It is also practical when data needs to be frequently transferred from the internal system to EUDAMED. This is possible with M2M with just a few clicks.

Technical requirements for M2M

Setting up the M2M interface is complex. Therefore, EUDAMED recommends outsourcing this to external service providers and using their interface. After all, M2M must be integrated into existing systems. Additionally, data must be transferred in the correct format in compliance with EUDAMED Business Rules. It is also necessary to protect the exchanged data from third-party access. Therefore, appropriate security measures and protocols must be established. Another effort is the interface itself. Two different systems must be made to communicate with each other.

In the mytracekey UDI Manager, the direct interface with EUDAMED (M2M) is available to our customers as an add-on. This means that only company-specific configurations need to be made. Then the data can be correctly assigned in EUDAMED.

The configuration process does not pose significant hurdles for our customers. Especially because we already know the specifics of the process and can guide them accordingly.

Security Aspects of Data Transmission

EUDAMED M2M communication uses the AS4 protocol via the CEF e-Delivery network to ensure standardized, secure, and encrypted data transmission between the mytracekey software and the EU database. The access point (AP) plays a central role in this process: Both our system and EUDAMED operate an AP that automatically exchanges and confirms message. Including encryption, authentication, and reliable delivery. In addition, key management processes are mandatory for setting up and using the interface: EUDAMED requires the creation, management, and, if necessary, regeneration of security keys to ensure the integrity and access control mechanism of the connection.

Step-by-Step Integration

The configuration process involves several steps. These include generating security keys and active access to the EUDAMED Playground and the EUDAMED production system. In addition, various documents must be exchanged with EUDAMED and us as the software provider in order to set up access point access. Finally, successful reporting of the first UDI DI and Basic UDI DI must be verified. The integration is carried out in accordance with the official EUDAMED documentation.

With this structured approach, you fully meet the technical requirements of the EUDAMED M2M interface and ensure a robust, secure, and standardized integration.

Why is the M2M Interface Preferable to XML Upload?

Using M2M is particularly suitable when large amounts of data need to be reported to EUDAMED. One hurdle with XML upload, the alternative to M2M, is the file size limitation. Officially, up to 300 UDIs per XML can be transferred per transmission. However, the data maximum cannot always be fully utilized, for example, if there are many attributes.

To avoid splitting XML files and a high number of individually uploaded files, M2M can be used. Here, there are no size limitations, and the transfer is fully automated.

M2M to EUDAMED is Worthwhile

If the data, as with the mytracekey UDI Manager, is also pre-validated according to EUDAMED Business Rules, nothing stands in the way of efficient, secure, and error-free transfer via M2M. Although it involves short waiting times for the customer during the initial setup, it is worthwhile from the first data transfer.

If you want to learn more about the M2M, data validation, and our software, simply schedule a demo appointment.

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