EUDAMED UDI/Device Module: Device Data and Registration Requirements
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
EUDAMED UDI/Device registration is an important requirement for manufacturers placing medical devices and in vitro diagnostic medical devices (IVDs) on the European Union market.
The UDI/Device module provides information about devices placed on the EU market and supports their identification and traceability.
For manufacturers, however, registering devices in EUDAMED is more than an administrative data-entry exercise. The information submitted needs to be accurate, complete and consistent with the manufacturer’s regulatory documentation.
Understanding the scope of the UDI/Device module and the challenges involved can help manufacturers assess their obligations and determine whether professional support is appropriate.
What is the Eudamed UDI/Device Module?
EUDAMED is the European Database on Medical Devices established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
The UDI/Device module is the part of EUDAMED dedicated to information about medical devices and IVDs. It supports the identification of devices and provides greater visibility of device information across the European Union.
Manufacturers are responsible for ensuring that the applicable information relating to their devices is correctly provided and maintained.
This information should accurately reflect the devices placed on the market and remain consistent with the manufacturer’s regulatory and product documentation.
For a broader overview of the EUDAMED registration process, see our EUDAMED Registration Guide for Manufacturers.
What Information Is Involved in EUDAMED Device Registration?
EUDAMED device registration involves a range of information relating to the manufacturer and the device.
Depending on the device and its regulatory status, relevant information may include:
Basic UDI-DI and UDI-DI information
- Manufacturer information
- Device characteristics and descriptions
- Device nomenclature information
- Regulatory information
- Certification information, where applicable
- Other information required by the UDI/Device module
The exact information required can vary depending on the type of device, its regulatory status and the applicable MDR or IVDR requirements.
Manufacturers should therefore consider EUDAMED device data alongside their existing regulatory and quality records rather than treating the database as a separate administrative exercise.
Nomenclature is also an important consideration. The European Medical Device Nomenclature (EMDN) is used as part of the EUDAMED registration process, meaning that manufacturers need to ensure their device information is appropriately aligned with the applicable nomenclature.
Why Does EUDAMED Registration Require Careful Preparation?
One of the main challenges with EUDAMED UDI/Device registration is ensuring consistency between the information submitted to EUDAMED and the manufacturer’s existing regulatory documentation.
Relevant information may originate from different internal sources, including regulatory records, UDI documentation, quality systems and product databases.
Differences between these sources can create issues during registration or require additional review and correction.
Common areas where inconsistencies may occur include:
- Device names and descriptions
- UDI information
- Manufacturer details
- Device characteristics
- Nomenclature information
- Regulatory and certification information
These issues can become particularly difficult to manage when a manufacturer has a large or complex device portfolio.
The challenge is not simply knowing what information EUDAMED requires. Manufacturers also need to ensure that the information is accurate, consistent and appropriately supported by their regulatory documentation.
For this reason, careful preparation and review can be an important part of an effective EUDAMED registration strategy.
Common Challenges With EUDAMED UDI/Device Registration
Complex Device Portfolios
Manufacturers with multiple devices, variants, product families or different regulatory statuses may need to coordinate substantial amounts of information.
The larger the portfolio, the more important it becomes to have a consistent approach to reviewing and managing device data.
UDI and Device Data Consistency
UDI information needs to remain consistent with the manufacturer’s broader product and regulatory records.
Where information has changed over time or is maintained across different systems, identifying discrepancies can require significant internal resources.
EMDN Nomenclature
The EMDN provides a common European nomenclature for medical devices and plays an important role in EUDAMED.
Selecting and maintaining appropriate nomenclature information can require regulatory knowledge, particularly for manufacturers managing diverse or technically complex portfolios.
Legacy Devices
Manufacturers may also need to consider devices covered by transitional provisions under the MDR and IVDR.
The registration requirements and applicable timelines can depend on the regulatory status of the device, meaning that legacy portfolios should be assessed carefully rather than treated in the same way as newly certified devices.
Ongoing Data Maintenance
EUDAMED registration should not necessarily be viewed as a one-time administrative task.
Manufacturers need to consider how relevant device information will be reviewed and maintained as products, regulatory documentation and other information change.
For companies with larger portfolios, managing this information can become a significant regulatory and administrative workload.
The UDI/Device Module and the 2026 EUDAMED Deadlines
The UDI/Device module became mandatory on 28 May 2026 as part of the progressive implementation of EUDAMED.
Another important date for manufacturers is 28 November 2026, which is relevant to the registration of applicable devices under the transitional provisions.
However, the requirements and applicable timelines can depend on the regulatory status of the device and whether transitional provisions apply.
Manufacturers should therefore assess their individual device portfolio rather than assuming that the same requirements apply to every product.
For a broader overview of the EUDAMED implementation timeline and mandatory modules, see our EUDAMED Roll-Out: Timeline, Mandatory Modules and Key Deadlines.
How CMC Medical Devices Can Help
Preparing and maintaining EUDAMED device information can require considerable regulatory and administrative resources, particularly for manufacturers with multiple products or complex portfolios.
CMC Medical Devices supports medical device and IVD manufacturers with EUDAMED registration activities, helping them prepare, review and manage the relevant information.
Our regulatory specialists can support manufacturers throughout the process, helping to reduce the administrative burden while ensuring that EUDAMED activities are handled with appropriate regulatory oversight.
Need Help With EUDAMED Device Registration?
If your company needs to manage EUDAMED UDI/Device registration but does not have the internal resources or expertise to handle the process efficiently, professional support can help.
CMC Medical Devices can support manufacturers with relevant EUDAMED registration activities and help manage the process on their behalf.
Contact CMC Medical Devices to discuss your EUDAMED registration requirements.
Frequently Asked Questions
Is EUDAMED UDI/Device registration mandatory?
The UDI/Device module is one of the EUDAMED modules subject to mandatory use under the applicable MDR and IVDR implementation requirements. The specific registration obligations depend on the device and its regulatory status.
Which devices need to be registered in EUDAMED?
Manufacturers may need to register applicable medical devices and IVDs in EUDAMED. The exact requirements can depend on the applicable regulation, device classification, regulatory status and transitional provisions.
What information is involved in EUDAMED device registration?
Information can include manufacturer details, Basic UDI-DI and UDI-DI information, device characteristics, nomenclature and applicable regulatory or certification information. The information required varies according to the device and its regulatory status.
What is the 28 November 2026 EUDAMED deadline?
28 November 2026 is an important transitional deadline relating to the registration of certain applicable devices. It is not a universal deadline that applies identically to every device or manufacturer.
Do legacy devices need to be registered in EUDAMED?
Legacy devices can be subject to specific requirements under the MDR and IVDR transitional provisions. Manufacturers should assess their individual products and regulatory status to determine the applicable obligations.
Can CMC Medical Devices manage EUDAMED registration on behalf of a manufacturer?
Yes. CMC Medical Devices can support manufacturers with EUDAMED registration activities, including the preparation, review and management of relevant device information.
