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

Manual Entry: A Transitional Option, Not a Sustainable Model

Manual entry in EUDAMED should not be seen as a “default” or recommended approach, but rather as a transitional solution that can be adapted to specific regulatory constraints in very limited scenarios.

In practice, manual entry is mainly suitable for:

• Very small structures or early-stage startups,
• With limited product portfolios,
• Operating on a single regulatory market,
• With stable products and very few updates.

Even in these cases, manual entry must be carefully supervised by qualified regulatory personnel to mitigate compliance risks.

Device Volume: No Longer the Decisive Criterion

Although experience suggests a tipping point around 200 UDI-DIs, volume alone is misleading. Manual entry can rapidly become inappropriate well below this threshold when manufacturers face:

• Frequent product updates or design changes,
• Expansion to additional regulatory markets,
• Increasing audit pressure on data integrity and traceability,
• Dependency on individuals for repetitive, low-value tasks.

Manual processes do not scale with regulatory complexity.

Automated Publication: Understanding the Real Differences

There are currently two automated publication approaches within EUDAMED. While they are often presented as equivalent, their operational reality and regulatory value are fundamentally different.

Solution 1: XML File Upload — Technically Heavy, Industrially Inefficient

XML file upload relies on EUDAMED’s native functionality but introduces significant constraints for manufacturers:

• It requires advanced XML/XSD skills and a deep understanding of EUDAMED’s data model,
• XML files are not business-user friendly and cannot be handled by regulatory teams without technical support,
• External technical providers are often required, increasing dependency and cost,
• No regulatory or operational confirmation is provided to the manufacturer regarding successful and complete integration of data into EUDAMED.

From an industrial standpoint, XML upload provides no added value:

• No end-to-end traceability of submitted data,
• No confirmation of effective data integration across EUDAMED modules,
• Manual error handling,
• High risk of silent failures or undetected inconsistencies.

As a result, XML upload is more complex than M2M, offers less control, and brings no tangible benefit for industrial manufacturers managing compliant product lifecycles. It is therefore poorly adapted to operational, audited environments.

Solution 2: Machine-to-Machine (M2M) — The Only Viable Industrial Approach

Machine-to-Machine (M2M) integration enables direct, controlled, and traceable communication between the manufacturer’s system and regulatory databases such as EUDAMED.

M2M ensures:

• Full confirmation of data integration,
• End-to-end traceability and audit readiness,
• Exception-based management,
• Alignment between source systems and regulatory publications.

Developing and maintaining an M2M connector internally is rarely sustainable due to technical and regulatory complexity. Specialized regulatory technology platforms provide the only realistic solution.

Ackomas’ M2M solution delivers a fully operational, production-ready integration, ensuring technical compliance while allowing regulatory teams to focus on data quality rather than data transmission.

M2M: A Misunderstood Simplicity

Many manufacturers still perceive M2M as complex, technical, or IT-heavy. This perception is largely inherited from past ERP or custom integration projects and does not reflect today’s reality.

In practice, M2M is the simplest and most user-friendly publication method for manufacturers:

• No files to generate, format, or upload,
• No XML skills required,
• No manual reconciliation between source data and regulatory systems,
• Clear technical and business confirmation that data has been successfully integrated.

For regulatory and quality teams, M2M is actually far easier to use than manual entry or XML, and miles away from the complexity often imagined by clients.

M2M shifts regulatory publication from a risky operational task to a controlled, transparent, and largely invisible process for manufacturers.

The Global Reality: Multiplication of Regulatory Databases

EUDAMED is no longer an isolated system. Manufacturers must now publish and maintain consistent product data across multiple regulatory databases, including:

• EUDAMED (EU),
• Swissdamed (Switzerland),
• GUDID (United States),
• AusUDI (Australia),
• SIUD (Brazil),
• SFDA databases and other emerging national systems.

Each database has:

• Its own data model,
• Its own validation rules,
• Its own timelines and update mechanisms.

This fragmentation makes local, manual, or file-based approaches structurally impossible to maintain.

Only a global regulatory data management strategy, based on a centralized repository and machine-to-machine integrations, allows manufacturers to:

• Maintain consistency across markets,
• Reduce compliance risk,
• Control change propagation,
• Ensure long-term auditability.

Without M2M, global regulatory compliance simply does not scale.

Product Master Data: From Theory to Reality

In theory, manufacturers aim for a single source of truth. In practice, regulatory product data is spread across quality, clinical, technical, and operational systems — many of which were not designed for regulatory publication.

Ackomas provides a compliant regulatory data repository designed specifically for MDR/IVDR and global regulatory requirements, with native M2M integrations ensuring secure and controlled publication.

Conclusion: A Strategic, Not Technical, Decision

Regulatory compliance is not optional — it is a market access condition and a trust indicator.

Manual entry is a temporary workaround suited mainly to startups or highly constrained situations. XML upload increases complexity without delivering industrial or regulatory value. The multiplication of regulatory databases definitively closes the door on fragmented approaches.

M2M is no longer an option — it is the foundation of sustainable global regulatory compliance.

Choosing a proven, operational M2M solution is now a strategic investment that protects compliance, scalability, and innovation.