EUDAMED Registration: Step-by-Step Guide (2026)
EUDAMED registration is the process by which medical device manufacturers submit their device-level data — Basic UDI-DI, UDI-DI, certificates, and related attributes — into the European Database on Medical Devices. Once mandatory, this registration becomes the regulatory anchor that connects every device placed on the EU market to its identification, traceability, and post-market obligations.
This guide focuses on what most manufacturers actually need to operationalize: the registration of devices and their identifiers. It covers Basic UDI-DI submission, UDI-DI linkage, certificate referencing, the practical sequence of steps, and the choice between manual entry and machine-to-machine (M2M) automation.
For broader context on the database itself, see our overview of EUDAMED and the six EUDAMED modules that structure the system.
Scope note. This article addresses device-level registration. Operational topics that fall outside ACKOMAS’ regulatory scope are not covered here.
Why EUDAMED registration matters
Beyond regulatory obligation under MDR (EU) 2017/745 and IVDR (EU) 2017/746, accurate EUDAMED registration delivers tangible operational value:
- Traceability — every UDI-DI is linked to its Basic UDI-DI, certificates, and post-market events, creating a continuous record from market entry to vigilance follow-up.
- Multi-market alignment — EUDAMED data structures (UDI-DI, nomenclature, attributes) align with parallel frameworks such as GUDID, Swissdamed, AusUDID, SUID, simplifying multi-market regulatory data governance.
- Audit-readiness — clean, current, and complete EUDAMED records substantially shorten Notified Body audits and competent authority reviews.
- Reduced regulatory non-conformity exposure — well-maintained records reduce the risk of regulatory non-conformity findings during inspections and renewals.
What gets registered in EUDAMED
EUDAMED device registration revolves around four interconnected objects:
1. Basic UDI-DI
The Basic UDI-DI is the regulatory anchor: a single identifier that groups devices sharing the same intended purpose, risk class, and essential design and manufacturing characteristics. It is the primary entity in EUDAMED and references certificates issued by Notified Bodies.
2. UDI-DI
The UDI-DI is the device-specific identifier carried on the device label and packaging. Each UDI-DI is linked to one Basic UDI-DI. Variants (size, configuration, packaging level) generally lead to different UDI-DIs grouped under the same Basic UDI-DI.
3. Device record (attributes)
The device record contains structured attributes: EMDN nomenclature code, MDR/IVDR risk class, intended purpose, status (on market, withdrawn, recalled), market countries, and additional fields required under MDR/IVDR Annex VI Part B.
4. Certificates
Certificates issued by Notified Bodies — including CE, design examination, and quality management certificates — are referenced by the Basic UDI-DI. The Basic UDI-DI references the certificate, not the other way around: this directional logic is essential when modelling the data.
Who must register devices in EUDAMED
Device-level registration is the responsibility of the manufacturer. Authorized representatives, importers, and distributors interact with EUDAMED in their own capacities, but the obligation to register the device, its Basic UDI-DI, UDI-DI, and certificate references rests with the manufacturer.
This guide assumes the manufacturer has already secured the prerequisites required to access EUDAMED. It focuses exclusively on the device-level registration workflow.
Step-by-step EUDAMED registration process
The following sequence reflects the operational order most manufacturers follow. Each step has its own data quality requirements and dependencies.
Step 1 — Prepare and consolidate master data
Before any submission, master data must be assembled and validated:
- Device portfolio inventory — every commercial reference, with packaging level, configuration, and intended purpose.
- Nomenclature mapping — every device assigned to its EMDN code (and, where relevant, GMDN as a cross-reference).
- Attribute set — risk class (MDR Annex VIII or IVDR Annex VIII), status, market scope, regulatory documentation references.
- Certificate inventory — all Notified Body certificates with their numbers, scopes, validity periods, and the Basic UDI-DI groupings they cover.
Data quality at this stage determines the entire downstream workflow. Corrections after submission are operationally costly.
Step 2 — Choose the entry method
Manufacturers register data either through manual entry in the EUDAMED user interface, or via the M2M (machine-to-machine) API, which exchanges structured data directly between the manufacturer’s systems and EUDAMED.
Globalization, accelerating change, and stricter regulations all point to the need for a dedicated platform that ensures data compliance and historical record-keeping.
Step 3 — Submit the Basic UDI-DI
The Basic UDI-DI is registered first. It carries the regulatory grouping logic and references the Notified Body certificates that authorize market placement. Each Basic UDI-DI submission requires:
- A unique Basic UDI-DI value, generated through an authorized issuing entity (GS1, HIBCC, ICCBBA, or IFA).
- The associated certificate references.
- The grouping rationale (intended purpose, risk class, characteristics).
Step 4 — Link UDI-DIs to the Basic UDI-DI
Each UDI-DI is registered and explicitly linked to its parent Basic UDI-DI. This step also captures device-level attributes (EMDN, status, market countries, packaging levels) and produces the granular records used for traceability.
Step 5 — Maintain, update, and notify
EUDAMED registration is not a one-time event. Manufacturers must keep records current throughout the device lifecycle:
- Status updates — placement on the market, withdrawal, recalls.
- Attribute changes — modifications to intended purpose, packaging, market scope.
- Certificate updates — renewal, suspension, or withdrawal of Notified Body certificates referenced by the Basic UDI-DI.
- Vigilance events — field safety corrective actions, field safety notices, and other post-market signals connected to the relevant UDI-DI.
Continuous data maintenance is what transforms EUDAMED registration from a compliance checkbox into a reliable regulatory data asset.
Registering legacy devices
Devices placed on the market under the former directives (MDD, AIMDD, IVDD) and benefiting from MDR/IVDR transition periods follow specific registration rules. They do not always carry a UDI-DI, and their handling in EUDAMED uses transitional identifiers (such as EUDAMED-DI) when no UDI-DI is available.
Vigilance events affecting unregistered legacy devices generally trigger short-deadline registration obligations. Our dedicated article covers these cases in detail: legacy devices under EUDAMED — obligations and exceptions.
Manual entry vs. M2M (automated) registration
Two registration paths coexist:
- Manual entry / XML — direct submission through the EUDAMED user interface. Suitable for very small portfolios and low risk with limited update frequency.
- M2M (machine-to-machine) — automated, secure, and bidirectional data exchange between internal systems and EUDAMED. Suitable for medium and large portfolios, frequent updates, and multi-market regulatory data governance.
The decision is structural: it shapes how data quality is enforced, how updates propagate, and how audit-readiness is maintained over time. The full comparison, including selection criteria, is available in our manual vs. automation guide.
Registration deadlines and timeline
EUDAMED registration timing is governed by Regulation (EU) 2024/1860 and the Commission Implementing Decision adopted in November 2025. Different module groups become mandatory at different dates, and the registration obligations follow the same staggered logic.
The complete chronology — including deadlines, transition periods, and module-by-module mandatory dates — is consolidated in our EUDAMED timeline 2025–2026.
Continue exploring EUDAMED registration with ACKOMAS
ACKOMAS is a Regulatory Data Governance platform built for medical device manufacturers. It synchronizes device data with EUDAMED, GUDID, Swissdamed, AusUDID, SFDA, SUID, automating registration, certificate linkage, attribute updates, and post-market data flows.
