EUDAMED UDI Device Registration Requirements: MDR/IVDR Data and May 2026 Mandatory Timeline

Quick answer

Is EUDAMED device registration mandatory? Yes. From 28 May 2026, manufacturers must submit UDI and device information in the EUDAMED UDI/Devices module for medical devices and in vitro diagnostic devices placed on the EU market under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860 set this deadline alongside three other mandatory modules. Registration is informational—competent authorities do not assess device records—but it is a legal obligation distinct from Actor module registration. Each device needs a unique Basic UDI-DI and UDI-DI; UDI-PI is not registered in EUDAMED. Only users with Proposer or Confirmer profiles can submit device data. Authorised representatives and importers cannot register devices, even though they must register as actors. Voluntary UDI/Device entry has been possible since October 2021 at https://webgate.ec.europa.eu/eudamed.

Who this applies to

This guide applies to economic operators who place devices on the EU market and must fulfil UDI obligations under MDR Articles 27–29 or IVDR Articles 24–26.

Primary users of the UDI/Devices module:

• Manufacturers — EU and non-EU manufacturers who assign UDI-DIs and are responsible for device registration data
• System and procedure pack (SPP) producers — entities that register systems or procedure packs under MDR Article 22 / IVDR Article 22

Roles that register in the Actor module but cannot register devices:

• Authorised representatives (AR) — mandatory for non-EU manufacturers under MDR Article 11 / IVDR Article 11, but ARs do not submit UDI/Device records
• Importers — must hold an SRN as actors under MDR Article 13 / IVDR Article 13, but cannot enter device registration data

Product scope covers MDR medical devices, IVDR in vitro diagnostic devices, legacy devices still marketed under transitional timelines, and old devices subject to separate data rules under Regulation (EU) 2024/1860. Device registration uses EMDN (European Medical Device Nomenclature) codes to classify products in EUDAMED.

Actor module vs UDI/Devices module: two separate obligations

EUDAMED splits economic operator identity from product data. Both modules become mandatory on 28 May 2026, but they serve different purposes and follow different workflows.

Practical rule: complete Actor registration and obtain SRN first, then register devices in the UDI/Devices module referencing that SRN. Device records link to the manufacturer's or SPP producer's actor identifier. Attempting device registration without an approved actor profile and appropriate user permissions will fail in the restricted EUDAMED portal.

Mandatory date: 28 May 2026 and the transition from voluntary use

The European Commission confirmed on 27 November 2025 that four EUDAMED electronic systems are functional under Commission Decision (EU) 2025/2371. Regulation (EU) 2024/1860 provides a six-month transition from Official Journal publication, making 28 May 2026 the date mandatory use begins for:

1. Actor registration
2. UDI database and device registration
3. Notified bodies and certificates
4. Market surveillance

The UDI/Devices module has accepted voluntary entries since October 2021. Manufacturers who already registered devices voluntarily should review records against current field requirements before the mandatory deadline. From 28 May 2026, placing devices on the EU market without required UDI/Device data in EUDAMED violates MDR/IVDR registration obligations.

Two remaining modules—Clinical Investigations and performance studies and Vigilance and post-market surveillance—are still under development with separate timelines. Do not conflate their availability with the May 2026 UDI/Device deadline.

Proposer and Confirmer roles: who can enter device data

Device registration in EUDAMED requires more than a valid EU Login. Users linked to a manufacturer or SPP producer actor must hold a Proposer or Confirmer profile—not Viewer alone.

Workflow for user access:

1. Economic operator obtains SRN through Actor module approval
2. Individual users submit access requests linked to the actor SRN
3. The actor's Local Actor Administrator (LAA) approves user access
4. LAA assigns Proposer or Confirmer profile for staff who will manage UDI/Device data
5. Approved users open the UDI/Device registration module and enter device records

Organisations should identify Proposers (data entry) and Confirmers (final approval) before the mandatory deadline. Viewer-only access is insufficient for compliance teams responsible for submission.

Basic UDI-DI and UDI-DI: identifier rules in EUDAMED

Each device placed on the EU market under MDR or IVDR requires two distinct identifiers in the UDI/Devices module:

Basic UDI-DI

The Basic UDI-DI is the primary identifier for a device model or group of devices sharing the same intended purpose, risk class, and essential design characteristics. It:

• Groups UDI-DIs under one regulatory device record in EUDAMED
• Appears on the EU declaration of conformity and in technical documentation
• Is not printed on individual device labels or packaging
• Must be unique per device under each regulation (MDR or IVDR)

UDI-DI (Device Identifier)

The UDI-DI is the identifier assigned to a specific device version or model variant. It:

• Is assigned by a UDI issuing entity (e.g. GS1, HIBCC, ICCBBA, IFA)
• Appears on device labels and packaging
• For GS1 issuing entity codes, EUDAMED validates a 14-digit UDI-DI format
• Must be unique for each device variant under the applicable regulation

UDI-PI is not registered in EUDAMED

The Production Identifier (UDI-PI)—batch number, serial number, expiry date, or manufacturing date—is part of the UDI carrier on labels but is explicitly excluded from the UDI/Devices module scope. EUDAMED stores device-level identifiers and characteristics, not unit-level production data. Manufacturers must still apply UDI-PI on labels per MDR Annex VI Part C / IVDR Annex VI Part C, but they do not enter UDI-PI values when registering devices in EUDAMED.

Device data fields and mandatory entries

The UDI/Devices module captures device characteristics beyond identifiers. Fields marked with a red asterisk in the EUDAMED user interface are mandatory.

Core data categories include:

• Regulation — MDR or IVDR
• Device type — MDR device, IVDR device, legacy device, or old device (each category triggers different field sets)
• Basic UDI-DI and UDI-DI — unique per regulation
• EMDN code — European Medical Device Nomenclature classification
• Risk class — per MDR Annex VIII or IVDR Annex VIII rules
• Device name and description — trade name and intended purpose summary
• Manufacturer SRN — links to Actor module registration
• Notified body and certificate data — when conformity assessment requires NB involvement (see below)
• Clinical size and characteristics — where applicable to device type
• Status fields — on market, no longer placed on market, etc.

Device registration is informational. The national competent authority does not assess device registration submissions—the data is stored for transparency, market surveillance coordination, and public searchability. This does not reduce manufacturer responsibility for conformity assessment, technical documentation, or labelling compliance.

Partial device data is publicly searchable on the EUDAMED public website. Restricted-area users see additional fields not displayed publicly.

Certificate and notified body linkage

When device conformity assessment requires notified body (NB) confirmation under MDR Article 29(3) or IVDR Article 26(2), the UDI/Devices module requires certificate information linked to the device record.

Certificate data interconnects with the Notified Bodies and Certificates module, also mandatory from 28 May 2026. Ensure NB certificate records exist or are consistent before linking them to UDI/Device entries.

Legacy devices and old devices: separate data rules

Regulation (EU) 2024/1860 establishes specific rules for devices that were lawfully placed on the market before full MDR/IVDR application or under transitional provisions. EUDAMED distinguishes:

Manufacturers with mixed portfolios must register each device under the correct category. Selecting the wrong device type triggers incorrect mandatory fields and may produce incomplete public records.

Legacy device registration timelines align with the 28 May 2026 mandatory date for the UDI/Devices module, but transitional MDR/IVDR market-access deadlines for specific legacy categories remain separate—check your device's transitional certificate or declaration status independently.

Role restrictions: AR and importers cannot register devices

A common compliance misunderstanding is assuming the authorised representative who verifies non-EU manufacturer actor registration can also submit UDI/Device data. EUDAMED explicitly restricts device registration:

Non-EU manufacturers must ensure their organisation—not the AR—holds Proposer/Confirmer user access linked to the manufacturer SRN obtained through the AR-verified actor workflow. Importers remain responsible for verifying that devices they place on the market are registered, but they do not enter the data themselves.

Step-by-step: register a device in EUDAMED

Phase 1 — Prerequisites

1. Complete Actor module registration and obtain manufacturer or SPP producer SRN
2. Register EUDAMED users and obtain LAA approval for access linked to the SRN
3. Assign Proposer or Confirmer profiles to staff responsible for UDI data
4. Assign Basic UDI-DI and UDI-DI per MDR Annex VI / IVDR Annex VI UDI rules
5. Identify correct EMDN code for the device
6. Determine device type — MDR, IVDR, legacy, or old device
7. Gather certificate data if NB confirmation applies under Art 29(3) MDR / Art 26(2) IVDR

Phase 2 — Create the device record

8. Log in to https://webgate.ec.europa.eu/eudamed (restricted area)
9. Open the UDI/Device registration module
10. Create a new device record and select the applicable regulation and device type
11. Enter Basic UDI-DI — verify uniqueness within your portfolio
12. Enter UDI-DI — confirm format validation (14-digit for GS1 issuing entity)
13. Complete all red asterisk mandatory fields — device name, EMDN, risk class, intended purpose, manufacturer SRN
14. Link notified body certificate information where required
15. Review data against label, declaration of conformity, and technical documentation

Phase 3 — Submit and maintain

16. Proposer saves and submits the draft record
17. Confirmer confirms and finalises the registration (where dual-role workflow applies)
18. Verify the record appears correctly on the public EUDAMED search
19. Update the record when UDI-DI changes, device status changes (e.g. no longer placed on market), or certificate data renews
20. Maintain internal QMS traceability between EUDAMED records, UDI carrier labels, and technical documentation

Checklist: UDI/Device registration readiness

• Manufacturer or SPP producer SRN active in Actor module
• EUDAMED users approved with Proposer or Confirmer profile (not Viewer alone)
• Basic UDI-DI assigned and documented on EU declaration of conformity
• UDI-DI assigned by recognised issuing entity; label artwork verified
• UDI-PI strategy defined for labels (not entered in EUDAMED)
• EMDN code selected for each device
• Correct device type selected — MDR, IVDR, legacy, or old device
• Certificate/NB data prepared for Class IIa+ MDR or Class B+ IVDR devices
• Device data matches labels, DoC, and technical documentation
• Legacy/old devices mapped to Reg (EU) 2024/1860 category rules
• AR and importer roles informed they cannot submit device records
• Internal deadline set before 28 May 2026 mandatory date
• Post-registration plan for updates when device variants or certificates change

Common pitfalls

1. Confusing Actor and UDI registration — SRN alone does not satisfy UDI/Device obligations; both modules require separate submissions before market placement from May 2026.
2. Viewer-only user access — staff with Viewer profiles cannot create or edit device records; request Proposer/Confirmer from the LAA.
3. AR attempting device registration — authorised representatives register as actors but cannot enter UDI/Device data; non-EU manufacturers must manage this internally.
4. Registering UDI-PI in EUDAMED — production identifiers belong on labels only; the UDI/Devices module excludes UDI-PI by design.
5. Wrong device type for legacy products — selecting MDR device instead of legacy device produces incorrect mandatory fields and incomplete records.
6. GS1 UDI-DI format errors — EUDAMED validates 14-digit format for GS1 issuing entity codes; truncated or padded codes fail validation.
7. Missing certificate linkage — Class IIa/IIb/III and Class B/C/D devices need NB certificate data when Art 29(3) MDR / Art 26(2) IVDR applies.
8. Assuming NCA approval of device data — device registration is informational; lack of NCA feedback does not mean data is accurate—manufacturers remain responsible for correctness.

FAQ

Is EUDAMED device registration mandatory?

Yes. From 28 May 2026, the UDI/Devices module is mandatory under Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860. Manufacturers must submit UDI and device information for devices placed on the EU market. Voluntary registration has been available since October 2021.

What is the difference between actor and device registration in EUDAMED?

Actor registration assigns an SRN to economic operators (manufacturers, ARs, importers, SPP producers). Device registration stores Basic UDI-DI, UDI-DI, and device characteristics linked to a manufacturer SRN. Both are mandatory from 28 May 2026 but serve different legal bases—MDR Art 30 vs Art 28–29.

What data is required for UDI registration in EUDAMED?

Each device needs a unique Basic UDI-DI and UDI-DI, EMDN code, risk class, device name, intended purpose, manufacturer SRN, and all red asterisk mandatory fields in the EUDAMED UI. UDI-PI is not registered. Certificate data is required when NB confirmation applies under MDR Article 29(3) or IVDR Article 26(2).

Can importers or authorised representatives register devices in EUDAMED?

No. Importers and authorised representatives must register in the Actor module and hold an SRN, but EUDAMED restricts UDI/Device registration to manufacturers and system/procedure pack producers with Proposer or Confirmer user profiles.

When does EUDAMED become mandatory for device registration?

28 May 2026 — six months after Commission Decision (EU) 2025/2371 was published on 27 November 2025. Four modules become mandatory on that date: Actor registration, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance.

What is the difference between Basic UDI-DI and UDI-DI?

Basic UDI-DI identifies a device model group and appears on the EU declaration of conformity—not on labels. UDI-DI identifies a specific device variant, appears on labels, and is assigned by a UDI issuing entity. Both must be registered in EUDAMED; UDI-PI is excluded.

How do legacy devices register in EUDAMED?

Legacy devices under Regulation (EU) 2024/1860 use a dedicated legacy device type in the UDI/Devices module with adapted field requirements. Manufacturers must select the correct device category (MDR, IVDR, legacy, or old device) to trigger the appropriate data set.

Does the competent authority approve device registration in EUDAMED?

No. Device registration is informational—the competent authority does not assess UDI/Device submissions. Manufacturers remain fully responsible for data accuracy and for conformity with MDR/IVDR labelling, technical documentation, and certification requirements.

Official sources

• European Commission — UDI/Device registration: https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en
• European Commission — The EUDAMED four first modules will be mandatory to use as from 28 May 2026: https://health.ec.europa.eu/latest-updates/eudamed-four-first-modules-will-be-mandatory-use-28-may-2026-2025-11-27_en
• European Commission — EUDAMED UDI Devices User Guide (PDF): https://health.ec.europa.eu/system/files/2022-04/md_eudamed_udi-devices-user-guide_en.pdf
• European Commission — EUDAMED help: UDI/Device module introduction: https://webgate.ec.europa.eu/eudamed-help/en/actor/topics-by-actor/all-actors/introduction.html
• European Commission — EUDAMED overview: https://health.ec.europa.eu/medical-devices-eudamed_en