Differences Between EUDAMED and GUDID: What Manufacturers Need to Know

For medical device manufacturers operating internationally, navigating multiple regulatory databases can be complex. EUDAMED (European Database on Medical Devices) and GUDID (Global Unique Device Identification Database) represent two major systems for managing medical device information in the European Union and the United States, respectively. While both databases share the common goal of improving device traceability and safety, they have fundamental differences that manufacturers must understand to ensure regulatory compliance.

Key Differences in Scope and Purpose

EUDAMED: A Comprehensive European Approach

EUDAMED is a European Commission initiative designed as a modular system for the oversight of medical devices within the European Union. Unlike GUDID, EUDAMED extends far beyond device identification and includes six interconnected modules covering:

●       Economic Operator Registration

●       Device Identification and Registration

●       Certificates and Notified Bodies

●       Clinical Investigations and Performance Studies

●       Vigilance and Post-Market Surveillance

●       Market Surveillance

This holistic approach aims to enhance transparency and coordination among national authorities across all stages of the medical device lifecycle.

GUDID: Focused on Identification and Traceability

Managed by the U.S. FDA, GUDID primarily supports the UDI (Unique Device Identification) system and focuses on the registration of device identification information. Its data model is simpler and more targeted, with the primary goal of improving the traceability of medical devices marketed in the United States.

Vocabulary and Rule Differences

One of the major challenges for manufacturers is navigating the differences in terminology and regulatory rules between these two systems.

Example 1: Terminology for Device Assemblies

In EUDAMED, under Regulation (EU) 2017/745, the following terms are used:

●       "System/Procedure Pack"

●       "Configurable Medical Devices"

●       "IVD Kits" (under Regulation (EU) 2017/746 for in vitro diagnostic devices)

In GUDID, similar concepts are referred to as:

●       "Kits" or "systems" without specific definitions

●       "Convenience kits" under the FDA’s UDI guidance

These terminological differences are not merely semantic; they can significantly impact device registration processes and applicable regulatory requirements.

Example 2: Handling of Packaging Levels

Packaging level management highlights the divergent approaches:

●       GUDID adheres to a logistics-based model compliant with GS1 standards.

●       EUDAMED departs from GS1 rules, enforcing its own specific constraints.

For example, in EUDAMED, a UDI-DI (Device Identifier) may only appear once in a packaging hierarchy, which can be challenging for manufacturers accustomed to U.S. practices.

Differences in Scope of Devices to Register

A significant difference lies in the scope of devices requiring registration:

●       EUDAMED mandates the registration of all medical devices marketed in the EU, including Class I and consumer-grade devices.

●       GUDID does not require registration for certain low-risk or consumer products.

As a result, manufacturers marketing products in both regions will typically need to register more devices in EUDAMED than in GUDID.

Data Model Comparison

In practice, EUDAMED and GUDID data models are not easily harmonized, complicating process alignment for manufacturers.

A notable feature of EUDAMED is the introduction of the Basic UDI-DI, a primary identifier not present in GUDID. This new identifier links devices with the same essential characteristics.

Practical Implications for Manufacturers

Given these differences, medical device manufacturers should adopt a strategic approach:

●       Avoid oversimplification: Simply transposing GUDID data to EUDAMED is usually insufficient and can lead to non-compliance.

●       Implement robust data governance: Establish a flexible data model that meets the requirements of both systems while ensuring data integrity.

●       Automate processes: For manufacturers with high device volumes, automating submissions to both systems reduces error risks and optimizes resources.

●       Train teams on system-specific requirements: Understanding the conceptual differences between EUDAMED and GUDID is crucial for compliance.

●       Stay proactive: Both systems are evolving; keeping up with regulatory updates is critical to maintaining a compliant strategy.

Conclusion

Understanding the differences between EUDAMED and GUDID is essential for medical device manufacturers aiming to succeed in both the European and U.S. markets. Beyond technical disparities, these systems reflect distinct regulatory philosophies that must be incorporated into a comprehensive compliance strategy.

In this complex landscape, a specialized solution like the one offered by Ackomas can greatly streamline regulatory data management by automating registrations and ensuring compliance with EUDAMED’s specific requirements.

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