EUDAMED Device Registration Deadline: November 28, 2026

The mandatory registration process in EUDAMED, the European Union's medical device database, has begun. Manufacturers benefiting from transitional provisions for their existing devices must complete the required device registrations by November 28, 2026. ValidRelay automates this process, eliminating the need for manual data entry for medical device companies.

The European Union is undergoing a significant digital transformation in the medical device sector. EUDAMED (European Database on Medical Devices), developed by the European Commission, aims to improve the registration, traceability, and transparency of medical devices.

In accordance with the European Commission decision published on November 27, 2025, the use of the first four EUDAMED modules became mandatory as of May 28, 2026.

This development marks the beginning of a new era for medical device manufacturers. In particular, the UDI/Device Registration module plays a critical role in managing the registration of medical devices placed on the European Union market.

November 28, 2026: A Critical Deadline for EUDAMED Device Registration

According to the transition timeline published by the European Commission, November 28, 2026 is the deadline for registering devices placed on the market before May 28, 2026, that fall within the relevant transitional provisions, in the EUDAMED UDI/Device module.

This date is particularly important for medical device companies operating in the European market that have not yet completed their device registrations.

However, it is important to note that this deadline does not apply to all devices. New MDR/IVDR devices placed on the market for the first time after May 28, 2026, must have their applicable registrations completed before being placed on the market.

Therefore, companies must not only monitor the deadline but also review their product portfolios to determine which devices are subject to specific registration requirements.

EUDAMED Registration Process for Manufacturers and SPPP Companies

The EUDAMED UDI/Device Registration module includes various registration processes for different economic operator roles and device types.

Companies operating as Manufacturers are responsible for submitting the relevant identification and registration information for medical devices placed on the market under their own name or trademark.

Businesses operating as System/Procedure Pack Producers (SPPP) must fulfill the registration requirements applicable to systems and procedure packs prepared under Article 22 of the MDR.

Depending on the device type and regulatory status, the following information may be required during the registration process:

• Basic UDI-DI and UDI-DI identifiers
• Device names and identification information
• EMDN classification codes
• Risk class and applicable regulatory information
• Manufacturer and economic operator information
• Applicable certificate and conformity information

Ensuring that this information is accurate, complete, and consistent is fundamental to a successful EUDAMED registration process.

Do You Have to Register Hundreds of Devices Manually?

Registering devices in EUDAMED can create a significant operational workload, especially for companies with extensive product portfolios.

Preparing the information for each device, verifying the required fields, completing missing data, and transferring records to EUDAMED can be time-consuming.

Moreover, the fact that the same device information already exists in companies' ERP systems creates another challenge: Re-entering existing data into a different platform.

This approach not only results in wasted time. Errors during manual data entry, missing information, and inconsistent records can also make the process more difficult to manage.

But is it possible for companies to use their existing ERP data to create EUDAMED registrations directly?

Automating EUDAMED Device Registration with ValidRelay

Developed to address this need among medical device companies, ValidRelay is a software solution that automates EUDAMED device registration processes.

ValidRelay's core approach is simple: Instead of recreating device data that already exists within your company, use your existing information to manage EUDAMED registrations.

With ValidRelay, companies can:

1. Import device information from ERP systems. Existing product data can be incorporated into the registration preparation process without manually recreating the information.
2. Manage device information from a centralized platform. Records intended for submission to EUDAMED can be reviewed, missing information can be completed, and necessary adjustments can be made.
3. Perform bulk device registration. Instead of creating each device individually through the EUDAMED interface, prepared device records can be submitted through automated integration.
4. Eliminate repetitive data entry. Particularly for extensive product portfolios, reducing manual operations can improve operational efficiency.

As a result, the EUDAMED registration process can be transformed from a labor-intensive manual operation into a centrally managed digital workflow.

Why Is EUDAMED Integration Important?

The introduction of mandatory EUDAMED device registration is not only a regulatory compliance development for medical device companies but also an opportunity to reconsider how product data is managed.

Especially for businesses managing large numbers of devices, establishing an automated data flow between ERP systems and EUDAMED can provide significant advantages.

Preparing device information in a centralized environment, reducing repetitive operations, and standardizing registration processes can help companies reduce their operational workload.

ValidRelay stands out in this transformation with its automation-focused approach designed for medical device manufacturers and system/procedure pack producers.

Complete Your Preparations Before the Deadline

As November 28, 2026 approaches, companies that have not yet completed registrations for devices covered by the transitional period should evaluate their current status.

The size of the product portfolio, the quality of existing data, and the time required to complete missing information can directly affect how long the registration process takes.

You do not need to manually re-enter all your device information to complete EUDAMED registrations.

With ValidRelay, you can use your existing ERP data, review device information, and automatically submit data to EUDAMED.

Digitalize your EUDAMED registration processes with ValidRelay.

Contact us to learn more about ValidRelay and discover its EUDAMED integration capabilities.

Sources

• European Commission — EUDAMED Overview
• European Commission — UDI/Device Registration
• European Commission — EUDAMED Transition Period: Devices & Certificates
• Regulation (EU) 2017/745 (MDR)
• Regulation (EU) 2024/1860

Disclaimer: EUDAMED registration requirements may vary depending on the regulatory status of the device, its date of placing on the market, and the role of the economic operator. This content is intended for general informational purposes only.