EUDAMED is moving the regulatory landscape in the EU forward. But regulatory change isn’t stopping there. Health authorities around the world are launching their own UDI databases – each with distinct product data formats, timelines, and technical requirements. 

Medical device manufacturers already report to the UDI databases like FDA’s GUDID in the US., China’s NMPA, and South Korea’s MFDS. Soon, systems like Swissdamed in Switzerland, TGA in Australia, ANVISA in Brazil, and the UK’s MHRA will join the list. The regulatory landscape is becoming more fragmented – and more demanding. 

To remain competitive, medical device manufacturers must shift from regional compliance efforts to a global UDI strategy. EUDAMED is just one step in a much broader transformation.   

Global compliance requires unified product data

Regulators aren’t the only ones relying on product data. Hospitals, Group Purchasing Organizations, logistics partners, and sustainability auditors also expect accurate, consistent, and synchronized information – no matter the platform or geography. 

Manufacturers need a single source of truth that supports: 

• Regulatory databases like EUDAMED, GUDID, and others  
• Commercial operations and partner networks  
• ESG and sustainability requirements 
• Supply chain traceability 

Aligning UDI content with GS1 standards and leveraging the Global Data Synchronization Network (GDSN) network allows manufacturers to maintain data integrity across borders. It ensures compatibility, reduces manual data work, and supports real-time updates between systems. 

Anticipate what’s next: vigilance is coming fast

The next EUDAMED module – Vigilance and Post-Market Surveillance – will go live in 2026. Unlike previous modules, it will follow a so called `big bang´ launch, becoming mandatory immediately.  

Manufacturers must plan now to test this module in 2025, even as they complete UDI compliance. Building a unified data pipeline is essential. This pipeline should support current and future modules with minimal rework, allowing for continuous adaptation to evolving regulatory needs. 

Build for scalability – not just compliance

At BYRD Health, we help medical device manufacturers move beyond short-term compliance. We design future-ready UDI ecosystems that support: 

• Regulatory submission 
• Commercial content management 
• Logistics optimization 
• ESG reporting requirements 

By working with a network of manufacturers, solution providers, and regulatory bodies, we help clients stay aligned with industry standards – and ahead of upcoming changes. 

Think beyond the next deadline 

Regulations will keep evolving. EUDAMED is a milestone, but not the endpoint. The real opportunity lies in building a scalable data infrastructure – one that connects compliance with commercial and operational value. 

BYRD Health guides manufacturers through every step of EUDAMED compliance – from custom test scenarios to final validation. Our experts streamline data flows and ensure readiness. With 2026 fast approaching, start now to stay on track and unlock market potential.