How to understand the EUDAMED database of the European Union and the significance of its implementation?

BRUSSELS – The European Commission has officially triggered the countdown for the mandatory use of the European Database on Medical Devices (EUDAMED). Following the publication of Commission Decision (EU) 2025/2371 in the Official Journal, medical device manufacturers and economic operators now face a strict legal timeline to align their products with the European Union's digital traceability framework.

For years, EUDAMED was a voluntary platform, with its full implementation delayed by technical complexities. However, under the amended Regulation (EU) 2024/1860, the EU shifted to a "gradual roll-out" strategy. By declaring the first four modules functional in late 2025, the Commission has effectively ended the era of optional participation.

The four modules now entering the mandatory phase are:

• Actor Registration: Manufacturers, importers, and authorized representatives.
• UDI/Device Registration: The central repository for device identification.
• Notified Bodies and Certificates: Registration of conformity assessments.
• Market Surveillance: Reporting and coordination between member states.

The transition period is divided into two critical milestones that will determine market access for medical technology companies:

1. May 28, 2026 – The "New Device" Gate: Starting on this date, any new medical device or in vitro diagnostic (IVD) placed on the EU market must be fully registered in the EUDAMED UDI/Device module. Furthermore, all "Actors" must have obtained their Single Registration Number (SRN) to legally operate.
2. November 27, 2026 – The "Legacy" Deadline: For devices already on the market before May 2026 (including MDD/IVDD legacy products), manufacturers have an additional six months to complete their data uploads.

The heart of this transition is the Unique Device Identification (UDI) system. Unlike previous national registries, EUDAMED requires a high level of data granularity. Manufacturers must provide not only the UDI-DI (Device Identifier) but also extensive "Master Data," including clinical references, storage conditions, and critical warnings.

Industry experts warn that the workload is often underestimated. "This is not just a simple data entry task," says a regulatory consultant. "It requires a complete audit of technical documentation and a robust internal IT infrastructure to ensure that the data in EUDAMED matches the physical labeling on the device."

Failure to meet these deadlines carries significant risks. Without a valid SRN and UDI registration, products may be blocked at customs or rejected by hospitals and procurement agencies that rely on EUDAMED to verify a device's legal status.

As the 2026 deadline approaches, the European Commission is urging companies to begin the "onboarding" process immediately to avoid a last-minute bottleneck in the system's support helpdesks.