What is EUDAMED, and do I have to register?

In short: EUDAMED is the EU's central medical-device database covering actor registration, UDI/device data, certificates, vigilance, and post-market surveillance. Manufacturers register as actors and obtain an SRN. Four of six modules — Actor Registration, UDI/Devices, Notified Bodies & Certificates, and Market Surveillance — became mandatory on 28 May 2026; Vigilance/PMS and Clinical Investigations follow later, unscheduled. Status as of 21 July 2026.

What EUDAMED actually contains

EUDAMED is built from six interlinked modules: actor registration, UDI/device registration, Notified Bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. Together they're meant to give regulators, Notified Bodies, and (for some data) the public a single traceable view of a device from registration through its post-market life, replacing the fragmented national systems that existed under the MDD.

What you actually have to do

Every manufacturer needs to register as an actor in EUDAMED and obtain a Single Registration Number (SRN) before placing a device on the EU market — this is now a firm, live requirement, not a future one. Under the framework set by Regulation (EU) 2024/1860, which amended the MDR and IVDR to make EUDAMED use mandatory six months after the Commission confirms modules functional, the Commission declared the first four modules functional in Commission Decision (EU) 2025/2371 of 26 November 2025, published in the Official Journal on 27 November 2025 — which is what made Actor Registration, UDI/Devices Registration, Notified Bodies & Certificates, and Market Surveillance mandatory on 28 May 2026. Non-EU manufacturers register through their Authorised Representative (MDR Article 11), and importers and Authorised Representatives are themselves actors needing an SRN. If you haven't registered and obtained your SRN, treat this as an already-due item, not a deadline to plan around — and note that SRN issuance involves competent-authority validation, so it isn't instantaneous. The remaining two modules, Vigilance and Post-Market Surveillance, and Clinical Investigations and Performance Studies, are scheduled for a later date not yet fixed.

Why the remaining two modules still need a status check

The first four modules are settled; the last two aren't yet, and EUDAMED's rollout has shifted dates before. Before building a compliance plan around Vigilance/PMS or Clinical Investigations specifically, confirm current status directly via the European Commission's EUDAMED information page rather than relying on a cached date from any secondary source, including this one.

Where next: MDR Annex VIII: How Device Classes Are Set · What changed from MDD to MDR, and what are the transition deadlines?

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