The European Commission has published an official notice confirming that the first four modules of EUDAMED are functional and meet the required functional specifications. This notice was published in the Official Journal of the European Union (OJEU) on 27 November 2025 after Commission Decision (EU) 2025/2371. In line with the transitional provisions introduced by Regulation (EU) 2024/1860, the publication starts a six-month transition period. As a result, EUDAMED mandatory use for the first four modules will apply from 28 May 2026, for new devices before market entry. Devices already on the market before 28 May 2026, whether legacy devices under MDD/IVDD or devices compliant with MDR/IVDR, have until 27 November 2026 before use of the first four EUDAMED modules becomes mandatory for them.
For companies working with medical devices, this milestone matters because it marks a clear shift from “readiness” to “required use” of EUDAMED for a set of core regulatory activities. While EUDAMED has been discussed for years and introduced in phases, the Commission’s publication provides a concrete date that organisations should plan around—particularly those that will need to register as actors, maintain device and UDI data, reference certificates issued by notified bodies, and interact with market surveillance processes through the database.
From 28 May 2026 onwards, EUDAMED becomes the mandatory channel for the scope covered by these modules: actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. In practical terms, organisations should expect that accurate, consistent, and up-to-date records in EUDAMED will be increasingly important not only for compliance, but also for operational continuity—because data quality issues can translate into delays, additional workload, and avoidable back-and-forth when information needs to be submitted or corrected.
This is also where the medical device technical file becomes highly relevant in day-to-day execution. The core fields and identifiers submitted to EUDAMED (including UDI/Basic UDI-DI, device descriptors, intended purpose, and certificate references) must remain aligned with what is controlled in technical documentation and expressed on labelling/IFU. Any inconsistencies between EUDAMED entries and the medical device technical file can trigger rework and questions—internally, from notified bodies, or in the context of market surveillance.
Even with the mandatory use date in May 2026, experience shows most of the real effort happens behind the scenes long before anything is submitted. It is rarely just a question of creating logins. Many organisations need time to confirm legal entity details for actor registration, map internal master data to EUDAMED fields, align UDI information (including Basic UDI-DI where applicable) across systems, and define internal governance—who prepares the data, who reviews it, and how changes are controlled over time. These steps are especially relevant for companies with broad portfolios, multiple legal entities, or complex supply chains, where responsibilities and data sources are distributed.
A pragmatic way to start is to treat EUDAMED preparation as a structured data and process project. This typically begins with a quick readiness review to identify what data already exists in a usable form and what needs standardisation or remediation. The next step is to define clear ownership and workflows, so that EUDAMED entries are not a one-off effort but can be maintained reliably as products, certificates, and organisational details evolve. This approach reduces last-minute pressure and helps avoid access bottlenecks close to the deadline, when many organisations may be trying to complete the same steps at once.
As EUDAMED mandatory use becomes the baseline expectation for core regulatory data exchange, organisations that invest early in clean master data, clear ownership, and technical documentation alignment will be in a better position to avoid friction—both for compliance and for everyday operations.
If you would like support with EUDAMED readiness for medical devices—including a gap assessment and regulatory scoping—our team can help you build a practical plan aligned with the upcoming mandatory use date.
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