Manual Entry or Automation: Which Approach Is Right for Registering Your Devices in EUDAMED?

Device Volume: A Key but Not Exclusive Factor

The number of product references, defined at the UDI-DI (or Master UDI-DI for optics) level, is an important element in determining your approach to registration within the EUDAMED UDI/Devices module.

Empirical experience shows a tipping point around 200 product references.

Below 200 product references:

• Data entry time is limited to a few weeks,
• Dual-entry verification helps limit errors,
• Compliance risk requires qualified personnel,
• Cost mainly depends on human resources.

Other factors, however, can make this approach ill-advised even with a limited number of products, such as:

• The annual volume of new devices or minor/major modifications,
• The need to publish on other regulatory markets beyond the European Union,
• The risk of losing motivation or qualified staff due to repetitive and unvalued tasks.

Above 200 product references:

This threshold makes automation increasingly relevant due to:

• A higher rate of data entry errors,
• Staff disengagement and the “Groundhog Day” effect,
• Tight deadlines to meet regulatory submission requirements,
• Uncontrolled costs linked to staff turnover and rework,
• The limited reporting features within EUDAMED,
• The need for manual procedures to ensure data integrity,
• The risk of non-conformities identified during audits — especially when data integrity relies on multiple Excel versions,
• Loss of public trust if product-related data quality is poor.

Additional Criteria for Automation

Beyond volume, several other factors justify automation, including:

• Annual frequency of new product introductions or updates,
• Publication requirements on multiple regulatory markets,
• Staff retention and motivation concerns.

Other internal criteria include:

• Data quality within your information system (consistency, harmonized formats, update policies),
• Resource capacity (budget conflicts between regulatory and innovation priorities, competing IT projects, limited regulatory expertise).

And intrinsic EUDAMED criteria such as:

• Multiplication of global regulatory databases,
• Data integrity between EUDAMED modules,
• Volume of mandatory data elements in the UDI/Devices module,
• Non-editable data elements requiring new UDI-DI creation upon modification,
• EUDAMED version upgrades (playground vs. production).

Automated Solutions

Rejecting a manual approach is the first step toward mastering published data.

However, while several automated options exist within EUDAMED, they differ greatly — and some come with hidden constraints.

There are two main automated publication methods:

• XML File Upload (semi-manual/semi-automated),
• Machine-to-Machine (M2M) integration.

Solution 1: XML File Upload

XML file uploads use EUDAMED’s native functionality. However, before using it, manufacturers must generate XML files compliant with EUDAMED’s data model — requiring XML/XSD expertise and a deep understanding of the regulatory structure. Unlike Excel, XML files are not easily editable without technical knowledge.

These skills are rare in-house. Qualified XML experts are highly sought after and difficult to retain. Manufacturers often rely on external technical providers, potentially losing control over processes and costs.

It is important to note that such providers bear no regulatory responsibility for file content or format — this remains solely with the manufacturer.

The European Commission generally discourages this approach due to its operational complexity. It may still suit low-volume manufacturers if well-managed.

Main technical constraints include:

• Multiple XML formats per data type and action,
• File upload limits (max 40 UDI-DIs per XML file),
• Manual error management without automated support.

Solution 2: Machine-to-Machine (M2M)

The M2M approach enables fully automated publication to regulatory databases like EUDAMED via direct system-to-system integration, following the European Commission’s technical specifications.

Few manufacturers develop M2M internally — it requires significant resources, advanced expertise, and continuous regulatory monitoring. Some large groups have tried building their own connectors, with mixed results.

The most reliable approach is to rely on a specialized platform developed by a regulatory technology provider familiar with the medical device industry. Such platforms ensure technical compliance, connector maintenance, and ongoing adaptation to regulatory updates.

Ackomas’ M2M solution offers these benefits, combining data traceability, integrity, and security with a user-friendly interface and exception-based management. This allows teams to focus on non-compliant data only while ensuring seamless publication to EUDAMED.

Fully operational in production, the Ackomas M2M solution reflects a deep understanding of MDR/IVDR requirements and the realities of the medical device industry. Its pricing structure balances robustness, compliance, and functionality — ensuring rapid and simple deployment.

Product Master Data: A Complex Reality

In theory, a Product Master Data Repository should serve as a single, centralized source of truth. In practice, especially for medical device manufacturers, multiple repositories exist for production, logistics, and regulatory purposes.

The regulatory product repository is critical under MDR/IVDR and for EUDAMED submissions. It often aggregates data from technical, quality, regulatory, and clinical systems — some of which must be entered manually due to lack of structure in legacy systems.

Ackomas’ platform offers a compliant, traceable, and secure environment for managing this regulatory data, integrating directly with the manufacturer’s information system.

Benefits of a Compliance Strategy

A robust compliance strategy ensures data quality, integrity, and traceability throughout the device lifecycle.

An automated M2M solution is a cornerstone of this strategy but does not replace data quality management at the source. Data quality is often overestimated, leaving regulatory teams unsupported.

Implementing an automated compliance solution provides:

• Reduced non-compliance risk and penalties,
• Higher efficiency through exception-based management,
• Better retention of skilled regulatory personnel,
• Strategic value of regulatory data aligned with marketing and commercial objectives.

Implementation of an M2M Solution

A regulatory submission project based on an M2M (Machine-to-Machine) solution must run certain task groups in parallel, such as:

• Understanding the scope and estimating the number of UDI-DIs (or Master UDI-DIs for optical devices),
• Prompt installation of the M2M solution,
• Data collection.

The final step involves exception-based data validation and data submission.

Success Factors

• EUDAMED implementation is as important as CE Technical File preparation — allocate a dedicated budget.
• Involve multidisciplinary teams (Regulatory, Quality, IT).
• Ensure data readiness before implementation.
• Choose a vendor specialized in medical devices and regulatory compliance.
• Select a proven, operational M2M solution with live EUDAMED production references.

Conclusion: A Strategic Decision

Regulatory compliance is not optional — it is the condition for market access and a mark of trust from healthcare professionals and patients.

The choice between manual entry and M2M automation is limited to very specific cases. Choosing a proven, automated, and compliant M2M solution is now a clear quality indicator — and a strategic investment supporting both compliance and innovation.

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With its modular architecture and native regulatory integrations, ACKOMAS transforms EUDAMED complexity into a smooth, secure, and efficient process.

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