EUDAMED 2026: Key Steps for Medical Device Manufacturers

The European Commission has confirmed the full EUDAMED 2026 timeline, a critical milestone for medical device manufacturers. With the latest Commission decision formally validating the first four EUDAMED modules and triggering a six-month transition period, the system’s phased rollout is now fixed and enforceable.   

• From May 28, 2026, all new medical devices must be registered in EUDAMED. 
• Existing devices must meet the final compliance deadline by November 27, 2026. 
• Vigilance obligations are expected to become mandatory in 2027. 

Despite clear deadlines, many manufacturers underestimate the effort required to prepare validated data and complete testing. Insights from early EUDAMED submissions and the osapiens EUDAMED eBook show a clear pattern: waiting until 2026 is not an option. 

Waiting Until 2026 Puts EUDAMED Compliance at Risk

The EUDAMED compliance deadlines are fixed, and additional extensions are not possible anymore. The real challenge is not the 2026 date itself, but the substantial workload required to prepare accurate submissions. Each upload triggers multiple validation steps, internal data revisions, coordination with Notified Bodies, and updates to quality management systems. These cycles often repeat as errors are uncovered, consuming time and resources across validation steps, internal updates, and external coordination. 

Manufacturers that delay preparation risk serious operational bottlenecks. As the mandatory deadline approaches, support resources, regulatory consultants, and Notified Bodies will reach full capacity, resulting in long delays for every correction cycle. Lessons from previous UDI implementation projects reveal a clear pattern: early adopters progress smoothly, while late starters struggle to resolve even basic issues under intense time pressure. 

Because the deadline is fixed while the workload continues to grow, companies that start testing and submitting data now gain a critical advantage: sufficient time to test, correct, and validate before 2026. Those who wait risk last-minute complications that could compromise full EUDAMED compliance. 

Data Quality: The Biggest Barrier to EUDAMED Compliance

Early EUDAMED testing reveals an uncomfortable but unavoidable truth: most manufacturers are far less prepared than they assume. Poor data quality remains the single greatest obstacle to achieving full EUDAMED compliance. 

Insights from the osapiens EUDAMED eBook show that nearly 60 percent of required device data is missing from internal systems, in the beginning or need a in-depth research internally. This is not a simple gap that can be resolved quickly – it reflects deeper issues in documentation practices, data ownership and cross-system consistency, all of which directly affect EUDAMED readiness. 

During testing, manufacturers often discover problems that surface only when data enters the EUDAMED validation pipeline. Public guidelines do not always match live IT validations, and dependencies between the EUDAMED modules create unexpected rejection loops. Devices that appear compliant on paper often fail once relationships between UDI data, certificates and future vigilance requirements are tested in real scenarios. 

This is why early EUDAMED testing is essential. The sooner manufacturers identify data gaps and inconsistencies, the more time they have to correct them. Without complete, accurate and consistently structured device data, no EUDAMED module can function efficiently and no manufacturer will reach compliance in time. 

3 Steps to Get EUDAMED Ready on Time

Regulatory Affairs teams need clear priorities to ensure EUDAMED readiness. In the coming months, manufacturers must focus on activities that directly influence compliance. These three steps consistently separate companies that progress smoothly from those that face critical delays. 

1. Conduct a Complete Attribute Assessment 
   A thorough review of all UDI-related device information is essential. This includes identifying missing attributes, verifying documentation accuracy, and ensuring internal consistency. Without a clean and complete data foundation, device registration workflows will be unreliable and prone to repeated errors. 
2. Begin Testing Immediately 
   Testing is not an administrative formality—it is the only way to understand the true maturity of your device data. Every test submission exposes issues that cannot be detected through static reviews. Corrections often impact certificates, quality processes, and data models. The earlier manufacturers begin testing, the more manageable these cycles become and the less risk they face of last-minute delays. 
3. Establish Validated and Stable Processes 
   EUDAMED readiness requires coordinated workflows across Regulatory Affairs, Quality, IT, and Notified Bodies. Processes should be transparent, version-controlled, and aligned with current regulatory expectations. Companies that implement validated procedures early maintain control of their timelines, while late starters are forced into reactive, inefficient workflows. 

EUDAMED and Beyond: Steps to Ensure Global UDI Readiness

EUDAMED compliance is just one piece of a global shift toward greater transparency, traceability, and regulatory oversight in the MedTech sector. Major markets (including the United States, China, South Korea, and Saudi Arabia) have already implemented UDI systems, while Switzerland, the United Kingdom, Australia, Brazil, and Canada are building new databases that will create additional obligations for device manufacturers. 

Establishing a strong EUDAMED process is therefore more than just meeting European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) requirements. It lays the foundation for global device data readiness. Manufacturers that implement a centralized, validated data strategy now will reduce redundancies, simplify future submissions, and improve access to international markets. Companies that focus only on meeting the minimum 2026 requirements risk repeatedly rebuilding processes as global UDI regulations evolve.

Get EUDAMED Ready Faster with osapiens HUB

The osapiens HUB for Medical Devices enables manufacturers to manage and validate all device and UDI information in a central, secure and fully validated environment. The solution supports early EUDAMED testing, ensures high data quality and integrates seamlessly with the European database. At the same time, it prepares manufacturers for global UDI requirements and facilitates compliant data exchange with hospitals, purchasing groups and regulatory authorities. 

Through deep industry expertise and close collaboration with the European Commission, GS1 and leading MedTech associations, osapiens ensures full transparency on regulatory updates and practical implementation. Manufacturers gain a stable framework for their data flows, streamlined processes, and reliable compliance readiness. 

Want to dive deeper into the topic? Register now for our next EUDAMED Webinar.