After several years of voluntary use, four of six EUDAMED modules are now mandatory. The milestone represents another step toward improved traceability, transparency, patient safety, and stakeholder awareness under the European Union’s Medical Device Regulation (MDR).
For devices newly placed on the EU market, registration requirements now apply for the mandatory modules. Legacy devices (i.e., devices placed on the market in conformity with the Directives and for which individual sales units continue to be placed on the market after the MDR/IVDR dates of application) and Regulation devices (i.e., devices placed on the market in conformity with the MDR/IVDR) that are already on the market as of May 28, 2026, have until November 28, 2026, to complete Actors and UDI/Device registration. In contrast, any device newly introduced to the market on, or after, 28 May 2026, must be registered in EUDAMED before being placed on the market.
In the context of economic operators, manufacturers, system and procedure pack producers (SPPPs), authorised representatives (RA), and importers are responsible for submitting the required device information to EUDAMED. This information includes actor registration data, the Basic UDI-DI, Master UDI-DI (where applicable), UDI-DI data, certificate information, and other device-related records. All submitted data must be accurate, up to date, readily accessible, and consistent with applicable regulatory requirements and the information reviewed and agreed upon by the Notified Body (e.g., device classification).
Registration can be an onerous process. A EUDAMED device record includes over 120 data fields among interconnected modules. In some cases, certain sections cannot be completed without correct information from another. For example, device registration cannot proceed without an active and validated Single Registration Number (SRN), which must first be obtained through the Actor Registration module. Manufacturers must submit Basic UDI-DI data, UDI records, and device attributes before a Notified Body can link certificates to the relevant devices. For devices that require Notified Body conformity assessment, a device registration will not progress from “Submitted” to “Registered” status until the Notified Body has uploaded and linked the corresponding certificate. As a result, successful registration often depends on timely and coordinated actions by multiple economic operators and the Notified Body.
It is important to note that the mandatory-use transition periods following publication of the relevant EUDAMED functionalities in the Official Journal of the European Union (OJEU) differ for economic operators and Notified Bodies. Economic operators are generally required to comply within 12 months of publication, whereas Notified Bodies are granted an 18 month transition period. Therefore, early coordination between manufacturers, other economic operators, and their Notified Body is essential to ensure timely, accurate, and compliant registration of devices in EUDAMED.
While EUDAMED registration takes time, companies who have organized, complete, and consistent data will likely have a smoother experience. Those who start early may avoid costly errors and associated delays.
UDI/Device Registration is one of the four now-mandatory modules. Other mandatory modules include Actor Registration, Notified Bodies and Certificates, and Market Surveillance. Vigilance and Post-Market Surveillance (VPMS) and Clinical Investigations and Performance Studies (CIPS) will become mandatory later.
Among the currently mandatory modules, UDI/Device Registration is one of the most complex. Economic operators are responsible for registering devices, systems, and procedure packs placed on the EU market. This involves establishing and maintaining the relationships between the Basic UDI-DI, UDI-DIs, device variants, certificates, and other device-specific attributes within EUDAMED.
As UDI data serves as the foundation for several interconnected EUDAMED processes, the accuracy and consistency of this information are essential for ensuring traceability, regulatory compliance, and the successful operation of other EUDAMED modules. Incorrect or incomplete UDI data can lead to registration delays, certificate-linking issues, and downstream compliance challenges.
Under MDCG 2018-1 Rev.4, devices grouped under the same Basic UDI-DI must share characteristics such as intended purpose, risk class, and design or manufacturing attributes. Manufacturers have long struggled with determining the right level of grouping. Over- or under-grouping devices can complicate traceability, technical documentation, certification activities, and ultimately EUDAMED registration.
UDI decisions affect technical documentation, certification activities, and EUDAMED registration. Incorrect groupings and other inaccuracies can trigger delays, nonconformities, and additional regulatory burden.
IQVIA MedTech helps manufacturers establish appropriate UDI strategies. We partner with clients to ensure devices are grouped properly as well as understand how UDI strategy affects technical documentation, certification activities, and future EUDAMED requirements.
We also support manufacturers in preparing accurate and compliant EUDAMED submissions by reviewing device data, UDI structures, and registration records prior to submission. In addition, we provide strategic guidance on the timing of EUDAMED registrations, helping clients align registration activities with certification milestones and planned market-entry dates. This proactive approach can help avoid out of date entries, facilitate certificate linking, and ensure devices are registered and ready for placement on the European market when required.
Manual registration may be the most practical option for device manufacturers with smaller portfolios, though it requires extensive data entry. Organizations with larger portfolios may want to experiment with either XML file upload or full machine-to-machine (M2M) integration with Enterprise Resource Planning (ERP) or Product Lifecycle Management (PLM) systems.
Legacy devices can add another layer of complexity due to less structured technical documentation, the absence of a Basic UDI-DI, fragmented regulatory histories, or simply the volume of devices requiring assessment. If a legacy device shares the exact same characteristics and identifiers as an MDR-certified device already registered by the manufacturer—including the UDI-DI, trade name, and catalogue/reference number—a separate registration of the legacy device is generally not required. However, a separate registration may still be necessary where vigilance-related information specific to the legacy device must be captured and maintained.
This exemption is narrowly defined and should be applied with caution. Any material difference between the legacy and MDR-certified device, including differences in labelling, packaging, configuration, or other device attributes, would generally necessitate a separate registration. Manufacturers should therefore carefully evaluate device equivalence and maintain appropriate justification for their registration approach.
Legacy devices have until November 28, 2026, to complete registration. A few ways to smooth the process include:
IQVIA MedTech EU regulatory experts bring decades of experience with MDD and MDR requirements. Our team supports manufacturers throughout the EUDAMED journey, from UDI strategy and regulatory consulting to public-facing documentation and post-market activities.
Support includes UDI and device grouping strategy, preparation and validation of compliant EUDAMED data submissions, strategic registration planning, coordination with Notified Bodies, and integration of EUDAMED activities into quality management procedures. We also assist with Summary of Safety and Clinical Performance (SSCP) development, Post-Market Clinical Follow-up (PMCF) activities, post-market surveillance programs, and ongoing regulatory compliance obligations.
By addressing these foundational elements early, manufacturers can reduce the risk of registration delays, data-quality issues, and compliance gaps, while positioning themselves to meet future EUDAMED requirements as additional modules become mandatory.
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