From 28th November 2026, all devices being placed on the market have to be registered in EUDAMED (subject to certain exceptions). Manufacturers that fail to comply may be readily identified by customers, competitors and other stakeholders through the public EUDAMED database. MDSS Consulting has supported manufacturers throughout their EUDAMED projects, from training and independent LAA access to full-service device registration. Contact us today to reduce the risk of last-minute bottlenecks, resource constraints, and compliance disruptions.
Why missing the registration deadline is dangerous
Being available for several years, the EUDAMED actor and device modules have already been used by many manufacturers ahead of the applicable deadlines.
Since 28th May 2026, new devices must be registered in EUDAMED before the first unit is placed on the market.
28th November 2026 is the deadline for all other devices that continue to be placed on the market (subject to certain exceptions). This category represents most devices currently available on the market. However, available data indicate that a considerable number of manufacturers have still not started or completed registering these devices in EUDAMED.
From 28th November 2026 onwards, these manufacturers will no longer be merely late but will be in a state of non-compliance.
Non-European manufacturers are under scrutiny of their authorized representative and the importers who have to verify that the device has been registered in EUDAMED. Based on our experience, some importers have already begun monitoring the compliance status of their suppliers ahead of the deadline and have indicated that they may refrain from purchasing devices that are not registered in EUDAMED.
These examples demonstrate that neglecting EUDAMED obligations can create significant risks for distribution channels and commercial activities. This effect is not limited to non-European manufacturers. As most EUDAMED device registration information is publicly accessible, healthcare providers, distributors, competitors, authorities and the public can verify whether devices have been registered and review much of the submitted information.
In addition to being subject to market surveillance activities by competent authorities, manufacturers may therefore face increased scrutiny from business partners and customers if EUDAMED obligations are not (properly) fulfilled.
Typical obstacles during the EUDAMED project
For this reason, ensuring that all devices are registered is only part of the challenge. It is equally important to ensure that the device information itself is accurate, complete, and appropriate for the device being registered.
EUDAMED requires a substantial amount of information during the registration process. The terminology used within the database often causes confusion and should be carefully assessed to ensure a consistent and harmonized registration approach across the entire device portfolio.
In some cases, the information required for registration is not readily available within the technical documentation. In others, the existing registration structure (Basic UDI-DI and UDI-DI) may not adequately reflect the characteristics of the device. As a result, manufacturers may need to generate missing information, revise existing data, or adjust their registration strategy before submission.
Once the device information has been prepared, the next challenge is submitting it to the database. EUDAMED offers three submission methods: manual registration, XML upload, and machine-to-machine (M2M) interface submission. However, the database currently does not provide a simple solution for bulk registrations.
With limited time remaining until the deadline, manufacturers with larger device portfolios often have to rely on external service providers that have already established XML conversion tools or M2M connectivity. Developing XML conversion capabilities or M2M interfaces internally typically requires significant effort, specialized IT expertise, and substantial resources, which can be particularly challenging for small and medium-sized companies.
How MDSS Consulting can help your EUDAMED project
MDSS Consulting can support manufacturers at every stage of their EUDAMED project, from strategic planning through to successful submission. We can help define a registration strategy tailored to your device portfolio and timeline, provide secure access to your company registration through an additional LAA account, and train your team on EUDAMED processes and functionality. For manufacturers seeking a turnkey solution, MDSS can manage the entire registration process on their behalf, including support for data collection, regulatory assessments, issue resolution, and direct submission of device data in EUDAMED. Also, we provide mere data submission packages if all regulatory questions are already answered by you. This allows your team to focus on core business activities while ensuring timely and compliant registrations.
Regardless of how you choose to approach EUDAMED registrations, the time to act is now. Ensure your device registrations are completed before 28th November 2026.
Contact us under: eudamed@mdssco.com
