What is EUDAMED and why is it becoming mandatory?
EUDAMED (European Database on Medical Devices) is the central EU database for medical devices and in vitro diagnostic medical devices (IVDs). It connects manufacturers, importers, authorized representatives, notified bodies, and authorities under a single system and serves the purposes of regulation, transparency, and market surveillance based on the EU MDR (2017/745) and the IVDR (2017/746).
Until now, EUDAMED has been available in phases and its use has been optional. The publication of the Commission Decision on November 27, 2025, stipulated that anyone with a regulatory obligation linked to one of the four modules must fulfill it in EUDAMED starting May 28, 2026. Parallel national systems, such as the German DMIDS, will no longer suffice.
Starting May 28, 2026, the use of these four modules will be mandatory.
Actor Registration
All economic operators (manufacturers, EU authorized representatives, importers) must be registered in the Actor module and hold a valid Single Registration Number (SRN). Without a valid SRN, placing products on the market in the EU is no longer permitted. Non-EU manufacturers must also register in the Actor module and additionally require an EU authorized representative to confirm the registration.
UDI & Device Registration
New products entering the EU market for the first time after May 28, 2026, must be registered in EUDAMED BEFORE their first placing on the market. This requires the entry of the Basic UDI-DI, all relevant UDI-DIs, and product attributes such as risk class and intended use.
Notified Bodies & Certificates
Notified bodies maintain certificate and decision information directly in EUDAMED. Complete stakeholder and device registration is a prerequisite for a product to be visible in the system.
Market Surveillance
Authorities actively use the Market Surveillance module to support their monitoring activities. Correct actor roles, up-to-date contact points, and complete device registrations are considered practical safety requirements.
The key dates summarised
- May 28, 2026: Four modules become mandatory. New products may only be placed on the market if they are fully registered in EUDAMED.
- November 28, 2026: As of this date, the registration requirement applies to all products that were placed on the market before May 28, 2026, and continue to be marketed thereafter.
- May 28, 2027: Notified bodies must have fully uploaded relevant legacy certificate data.
- Separate timeline: The Vigilance and Clinical Investigation modules will not become mandatory until after a separate statement of functionality, expected in Q2 2027.
WQS support for EUDAMED
WQS has been guiding medical device and IVD manufacturers through regulatory requirements in the EU for over 30 years. With the EUDAMED requirement taking effect on May 28, 2026, operational requirements will come into play, which we address through a clear support process:
- EUDAMED Readiness Check: We analyze the current status of your Actor Registration, UDI data, product registrations, and certificate logic, and guide you through the structured preparation of all registration data.
- MDR/IVDR Compliance: Before the deadline, we verify whether your EUDAMED data aligns with your technical documentation, IFU, and certificates, and integrate the registration requirements with your ongoing MDR/IVDR processes for technical documentation, PMCF/PMPF, PSUR, and collaboration with Notified Bodies.
- EU Authorized Representative (EU-REP): Non-EU manufacturers must appoint an EU-based authorized representative to confirm their actor registration in EUDAMED. WQS assumes this legally required role of EU Authorized Representative, including confirmation in the Actor Module and management of the SRN.
EUDAMED has long been a regulatory promise with deadlines that kept getting pushed back. Now, however, it is no longer a project for the distant future. Starting May 28, 2026, EUDAMED will be a central component of regulatory compliance for MDR and IVDR companies.
WQS is by your side: whether as your EU Authorized Representative, as a guide through your EUDAMED registration process, or as a regulatory sparring partner for your MDR/IVDR compliance.
Learn more about our MDR services and IVDR services.
Sources:
https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
https://health.ec.europa.eu/medical-devices-sector/new-regulations_de
https://www.bfarm.de/DE/Medizinprodukte/Ueberblick/Europa-und-EUDAMED/Uebergang-DMIDS-zu-EUDAMED/_artikel.html?nn=986770
