THE LEGAL LIABILITY OF THE MANUFACTURER
A common misconception is that the process can be delegated to the Authorized Representative (EC REP) or is managed by the Notified Body (NB). In reality, the manufacturer is the sole legal entity responsible for data integrity, accuracy, and submission.
The process requires a meticulous cleanup of internal databases and a deep understanding of the system’s technical specifications. Waiting until the last minute risks critical compliance failures, which would trigger a mandatory suspension of market placement throughout the entire European Union.
THE NEXT MILESTONE: NOVEMBER 27, 2026
The countdown continues, and the next crucial milestone is set for November 27, 2026. In five months, the mandate will extend to “legacy” devices (MDD/IVDD) and to already compliant devices marketed before May 28, 2026. This deadline risks creating a dangerous bottleneck for uploading UDI codes.
DATA GOVERNANCE
Companies must act now, validating their workflows and verifying data quality to avoid being caught unprepared. The transition to EUDAMED is now a strategic corporate priority, and compliance can no longer be postponed. Is your data ready?
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