Community
osapeers.org
This article is available in
About this article
Guest Author
AuthorAssigned categories
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.
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:
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.
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.
At BYRD Health, we help medical device manufacturers move beyond short-term compliance. We design future-ready UDI ecosystems that support:
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.
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.