EU Regulation 2024/1860 includes an amendment to the MDR & IVDR regarding a gradual rollout of Eudamed modules and a subsequent change in compliance timelines for manufacturers.

Regulation (EU) 2024/1860, adopted on 13 June 2024, introduces significant updates to the European regulations governing the rollout of the Eudamed database, as well as the obligations related to the supply of medical devices and in vitro diagnostic devices.

Instead of waiting for implementation of all 6 modules to be finalized before requiring compliance, a gradual roll-out strategy will be used, with compliance required 6 months after each module is audited and published. This is intended to streamline the implementation of Eudamed and improve communication regarding the availability of medical devices and diagnostics across the EU.

Medical devices placed on the EU market will require UDI data registration in Eudamed. Medical device distributed exclusively outside the EU does not yet need to have UDI data registered in Eudamed. In the United States, the Unique Device Identification (UDI) system is regulated by the U.S. Food and Drug Administration (FDA) under the FDA UDI Rule (21 CFR 830).

The core modules of Eudamed (device registration, certificates and notified bodies information) are required to be operational by Q1 2025, with publication in Q2 of 2025. It is expected that by 1 January 2026 the additional Eudamed modules, including clinical investigations, post market surveillance and vigilance reporting will be fully integrated.

New devices placed on the market after this date will need to be registered in Eudamed as part of the initial market entry process, with a July 2026 deadline for registration of existing and legacy devices. An updated roadmap is available at the European Commission website.

However, there are practical challenges ahead for manufacturers, particularly considering the estimated 350,000 EUDAMED registrations likely represents only 10-15% of the expected registrations as the July 2026 deadline approaches. This will put the system (EU commission website, helpdesk, IT / personnel etc.) under enormous strain and could result in unexpected and costly delays for manufacturers.

It is therefore highly recommended to plan and implement your strategy for EUDAMED compliance as soon as possible and avoid being caught up in the last-minute rush of applications at the deadline. The European Commission has endorsed recommendations to register by July 2025 to avoid any unexpected delays or difficulties.