The European EUDAMED database is set to become the operational core of the MDR (EU) 2017/745 and IVDR (EU) 2017/746 regulations. While many manufacturers are aware of its existence, there remains a dangerous underestimation of the effort required for device registration. It is not a mere bureaucratic formality, but a binding requirement for maintaining access to the Single Market.

UPCOMING DEADLINES: MAY AND NOVEMBER 2026

The regulatory timeline dictates two crucial milestones. From 28 May 2026, as part of the MDR or IVDR certification process, all devices must be fully registered in EUDAMED.

Subsequently, by 27 November 2026, the obligation will extend to so-called ‘legacy’ devices—those placed on the market under MDD/IVDD certificates during the transition period—as well as all MDR- or IVDR-compliant devices marketed before 28 May 2026. These tight deadlines are creating a bottleneck that requires proper planning to ensure the complete upload of UDI (Unique Device Identification) data.

THE MANUFACTURER’S LEGAL RESPONSIBILITY

A common mistake is believing that the process can be delegated to the Authorized Representative (EC REP) or managed by the Notified Body (NB). In reality, the manufacturer is the sole legal entity responsible for the integrity, accuracy, and submission of the data.

The operation requires meticulous cleaning of internal databases and a deep understanding of the system’s technical specifications. Waiting until the last moment means exposing oneself to critical compliance risks, with the mandatory suspension of placing devices on the market throughout the European Union.