At the beginning of August 2025, EUDAMED contained around 800,000 registered medical devices. By the time this article was published in February 2026, this number has grown to over 1.2 million devices. This corresponds to an increase of roughly 400,000 products within half a year. For comparison: the European Commission conservatively estimates a total of around five million medical devices that need to be recorded. If the current pace does not increase significantly, many manufacturers will likely not meet the May 28, 2026 deadline. The apparent lack of urgency indicates to us that EUDAMED is often viewed as a one‑time project rather than an ongoing process.

Many stakeholders underestimate the workload involved with the MDR/IVDR database and often delay addressing it. To assist with the upcoming EUDAMED tasks, we have developed the ideal long-term solution: the mytracekey UDI Manager. In this article, you will discover what makes EUDAMED a long-term project and why the UDI Manager is the perfect companion for it.

What Makes EUDAMED a Long-Term Project?

Every EUDAMED entry begins with the time‑consuming collection of product master data. Depending on the number of UDIs within a company, this process alone can take several weeks or even months. The data often originates from various Excel files, ERP systems, or even physical binders, making consolidation even more challenging.

After collecting the data, the next question arises: Which information does EUDAMED actually require?
The complexity of the MDR and its database demands specific expertise. The collected data must be filtered, and users must know which attributes are mandatory, which are optional, and where to find this information.

Once the data is prepared, one might assume it only needs to be entered. But even this step is more complicated than expected:

• Manual entry is extremely time‑consuming,
• the XML bulk upload is still significantly limited,
• and EUDAMED is unavailable during maintenance periods.

All of this costs valuable time that many companies have not planned for.

Even when all the UDIs are uploaded to EUDAMED, the project does not end here. As history shows, MDR requirements and, therefore, EUDAMED requirements change over time. Suddenly, previously submitted data is outdated because certain attributes expire while new ones must be added – a recent example: The update of EMDN codes. For 50 UDIs, this task is annoying but manageable. For more than 500 UDIs, it quickly becomes a major undertaking. A suitable solution can help enormously here.

What Makes the UDI Manager a Long-Term EUDAMED Solution?

For EUDAMED, the mytracekey UDI Manager is an ideal long-term solution for managing product data continuously through a defined process. The UDI software ensures cost‑efficient, compliant, and audit‑ready handling while allowing users to update their UDI data without complications.

Advantages of the mytracekey UDI Manager compared to other upload methods:

• Always updated with every change in EUDAMED and MDR/IVDR.
• Scales globally when emerging markets and new regulations appear.
• Provides long‑term security, including audit trails and verifiable compliance processes.
• Offers a simple workflow for updating data, including correct versioning.

Regulatory requirements continue to evolve, both within and beyond the EU. MDR and IVDR were recently updated, and new global regulations are emerging, such as AusUDID and swissdamed. The UDI Manager evolves accordingly. Updates are implemented quickly, and the software functions are continuously being developed further, for example to cover new regulations.

Why One-Time Solutions Can’t Keep Up

One‑time upload solutions are not flexible enough for a heavily regulated industry like medical technology. While smaller bug fixes and security updates may be free, major updates can quickly result in unexpected costs. When changes occur within the UDI module, additional UDI regulations arise, or new EUDAMED modules are introduced, one‑time software solutions cannot compete with the advantages of the UDI Manager.

Offers such as one‑time data uploads are also not future‑oriented. Outsourcing such projects can create dependency. When regulatory updates require UDI data revisions, you must either update the data yourself, requiring knowledge of EUDAMED, or purchase another one‑time upload service. A growing product portfolio is usually not considered in such services, making them non‑scalable.

Another one‑time approach we frequently encounter is internally developed software. Companies often underestimate the high maintenance effort and associated costs. If the internal IT department must continue its regular responsibilities, there is usually no capacity to adapt the in‑house tool to EUDAMED changes. As a result, it would quickly become outdated or offer only limited functionality.

The Price of Our EUDAMED Long-Term Solution

How is the price for the mytracekey UDI Manager calculated when using it as a long-term EUDAMED solution? Two sample calculations:

Example Calculation No. 1

The manufacturer has 300 UDIs. Due to regular product changes (e.g., seasonal items), continuous use is practical, so the FULL package with an annual contract is selected. The package includes 100 UDIs; each additional UDI costs €0.04. No M2M connection is needed.

• UDI Manager FULL costs €99 per month plus €8 for additional UDIs = €1,284 per year.

Selected Package:	FULL
Number of SRNs included:	1
Number UDIs:	300
Base price:	99,00 € / month
Additonal UDIs:	200
Cost for additional UDIs:	8,00 € / month
Total price:	107,00 € / month 1284,00 € / year

Example Calculation No. 2

The manufacturer has 2,700 UDIs across two companies (two SRNs). Due to the large product range and frequent changes, an M2M connection is advisable. The PREMIUM package meets these needs, allowing up to three SRNs and including M2M.

• Base price: €179 per month plus €96 for additional UDIs = €3,300 per year.

Selected Package:	PREMIUM
Number of SRNs included:	3
Number UDIs:	2.700
Base price:	179,00 €/Monat
Additonal UDIs:	2.400
Cost for additional UDIs:	96,00 €/Monat
Total price:	275,00 €/Monat 3300,00 €/Jahr

Our pay‑as‑you‑use model provides suitable options for companies of any size. In addition to FULL and PREMIUM, there is an ENTERPRISE package for companies with over 3,000 UDIs and a EUROPE package including M2M connection and swissdamed compliance. The price calculator also offers a transparent and individualized cost overview.

Long-Term Solution for a Long-Term Project

Thanks to the UDI Manager’s transparent pricing model, annual costs remain manageable and easy to plan. At the same time, companies benefit from a fully auditable process that ensures safety and traceability in all UDI‑related tasks. Our software remains consistently up to date, delivering a long‑term solution for efficient and scaleable UDI management.

All data remains centrally stored, giving the responsible teams complete oversight at all times. With a clearly defined single point of truth for all UDI data, manual coordination efforts are greatly reduced. This ensures that all stakeholders always work with consistent, current, and error‑free data, while lowering effort and simplifying regulatory reporting.

If you are interested, feel free to join a non‑binding product demo.