Time is ticking. Medical device manufacturers face a hard deadline: by January 2026, the use of several core modules of EUDAMED will become mandatory. Manufacturers must act decisively in 2025 to ensure operational readiness.

Falling behind is not an option. Manufacturers that prepare early will not only meet compliance requirements – they’ll sharpen their competitive edge in an increasingly regulated market.

EUDAMED – The backbone of EU Device Regulation

The European Commission designed EUDAMED as a centralized platform to enhance medical device traceability, to increase transparency, and to improve patient safety across the EU. It supports the enforcement of Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

EUDAMED integrates six interoperable modules, each focused on a distinct regulatory function – from Actor and UDI/Device Registration to Clinical Investigations, Vigilance and Post-Market Surveillance. It connects manufacturers and local authorities within a shared digital framework, streamlining cross-border collaboration and data sharing.

Data quality is the real challenge

Medical device manufacturers can’t meet EUDAMED requirements by submitting static data alone. They must ensure that every data point is complete, accurate, and – most critically – consistent. That consistency must extend not only within EUDAMED, but also across global regulatory databases and align with the expectations of trading partners internationally.

Most organizations struggle here. Even those with robust internal systems often uncover data discrepancies once they begin using EUDAMED. Mismatches between internal data formats and expectations from regulators are a common challenge.

Don’t wait – start testing early

At BYRD Health, we’ve supported medical device manufacturers of all sizes in getting EUDAMED-ready. The biggest takeaway: real progress starts with hands-on testing. Even the most mature organizations uncover critical gaps once they begin real-world testing. In fact, on average, 60% of required UDI information is missing or misaligned within internal systems.

Early testing provides manufacturers with a safety buffer. It enables teams to identify and correct discrepancies without disrupting operations. Integrating global data standards like the Global Data Synchronization Network (GDSN) helps ensure that the information submitted to EUDAMED is aligned with what’s shared across hospitals, distributors, supply chain partners, and group purchasing organizations.

Set July 2025 as your real deadline

EUDAMED Actor Registration, UDI/Device, Notified Bodies & Certificates and Market Surveillance modules are live and will be mandatory in January 2026. But: Start earlier to avoid bottlenecks. By late 2025, the resources in the ecosystem – solution providers, consultants and help desks – will be fully booked.

Companies that complete EUDAMED testing and validation by July 2025 will avoid resource constraints and retain flexibility to resolve last-minute issues in full portfolio – without compromising quality.

Your 5-step EUDAMED action plan for 2025

1. Audit your product attributes against EUDAMED UDI requirements
2. Register actors and begin device-level testing
3. Map your internal data flows across business units and systems
4. Cross-check data consistency with external databases like FDA’s GUDID
5. Engage experienced partners to validate processes

Start now – unlock long-term value

EUDAMED compliance is mandatory. But it also offers companies a strategic opportunity to strengthen data infrastructure, improve product visibility, and gain a competitive edge across global markets.

Get the ebook now and get ready for EUDAMED.