EUDAMED Guide 2026: Mandatory Modules, Deadlines & Registration

EUDAMED Guide 2026: What Is Mandatory Now and What Manufacturers Must Still Do

EUDAMED — the European Database on Medical Devices — is the IT system established by Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It is intended to give a living picture of devices on the EU market: who the economic operators are, which devices and certificates exist, and (when later modules go live) clinical and Vigilance information in a more integrated form.

For years, manufacturers planned against a moving target: modules available for voluntary use, national registration workarounds, and repeated delays. That phase changed in late 2025 and mid-2026.

This guide is written for manufacturers, authorized representatives (ARs / EC-REPs), importers, and regulatory teams that need a current picture of:

• which modules are mandatory as of 28 May 2026
• the legal trigger (Commission Decision (EU) 2025/2371)
• device registration timing for new vs already-placed devices (including legacy devices)
• what is still not mandatory
• practical compliance steps and how to monitor further Commission updates

It is not legal advice. Confirm obligations against the MDR/IVDR as amended (including Regulation (EU) 2024/1860), Decision (EU) 2025/2371, and the Commission’s current EUDAMED pages and Q&A.

Status Snapshot (as of August 2026)

Topic	Status
Mandatory use start (first four modules)	28 May 2026
Legal notice of functionality	Commission Decision (EU) 2025/2371 (26 November 2025; OJEU 27 November 2025)
Transition logic	Under Regulation (EU) 2024/1860, mandatory use generally starts 6 months after publication of the functionality notice for the relevant modules
Modules mandatory now	Actor registration; UDI/Device registration; Notified Bodies & Certificates; Market Surveillance
Not in the first mandatory set	Clinical Investigations & Performance Studies; Post-market surveillance and vigilance (under development / not yet declared functional for mandatory use)
Already-placed device registration	Where registration is required: devices placed on the market before 28 May 2026 and still placed on the market from the mandatory-use date are generally expected to be registered by 28 November 2026 (see device timing section; confirm against Regulation (EU) 2024/1860 and Commission materials)

The European Commission’s EUDAMED overview page states that as of 28 May 2026 the four modules listed above became mandatory to use, and it announced that the first four modules became mandatory since that date.

What Is EUDAMED?

EUDAMED is a web-based Commission IT platform that integrates several electronic systems so regulators, notified bodies, economic operators, and (for public parts) healthcare professionals and the public can access structured information about devices and actors.

It is not optional for operators in scope once the relevant module obligations apply. Non-compliance can block lawful placement on the market and trigger competent authority enforcement.

Who uses which parts?

• Manufacturers — actor registration (SRN), device/UDI data, linking to certificates where applicable
• Authorized representatives — critical for non-EU manufacturers; often the registered actor interface in practice
• Importers and certain other economic operators — actor registration duties under MDR/IVDR
• Notified bodies — certificate and designation-related data in the NB & Certificates module
• Competent authorities / Commission — market surveillance module and coordination
• Public / HCP — public website views of selected device and certificate information (scope depends on module and release)

The Six Modules — Mandatory vs Not Yet

EUDAMED is structured around six interconnected modules plus a public website (Commission numbering below). Gradual roll-out (enabled by Regulation (EU) 2024/1860) allows modules to become mandatory when declared functional, rather than waiting for all six.

Module 1 — Actor registration (mandatory since 28 May 2026)

Registers economic operators (manufacturers, authorized representatives, importers, system/procedure pack producers, and others in scope). Successful registration yields a Single Registration Number (SRN) used across EUDAMED interactions.

• Available voluntarily since December 2020 (Commission materials).
• Mandatory since 28 May 2026.

If your organization places devices on the EU market and still lacks a validated actor registration/SRN where required, this is an immediate priority — device registration depends on actor identity.

Module 2 — UDI and device registration (mandatory since 28 May 2026)

UDI/device data, including Basic UDI-DI and device identification data required under MDR/IVDR. This is the core device registry for transparency and traceability.

• Available voluntarily since October 2021 (Commission materials).
• Mandatory since 28 May 2026 for devices in scope of the mandatory-use rules (timing differs for devices already on the market — see below).

Module 3 — Notified bodies and certificates (mandatory since 28 May 2026)

Designation scope of notified bodies and certificates issued, suspended, restricted, or withdrawn. Essential for verifying CE certificate status in the EU system.

• Available voluntarily since October 2021, with noted exceptions for certain scrutiny/CECP functionalities in Commission materials.
• Mandatory since 28 May 2026.

Module 4 — Clinical investigations and performance studies (not in first mandatory set)

Commission overview (2026): under analysis / not part of the four modules declared functional in Decision (EU) 2025/2371. Practical Q&A on gradual roll-out explains that remaining modules will be released for mandatory use when ready; for some later modules there may be little or no voluntary-use window.

Module 5 — Post-market surveillance and vigilance (not in first mandatory set)

Commission overview (2026): in development. Serious incident reporting, FSCAs, and related electronic vigilance workflows in EUDAMED become mandatory only when this module is declared functional and its own transition clock runs — until then, applicable transitional/national rules and Directive-era pathways described in the MDR/IVDR transitional provisions remain relevant. Do not assume Module 5 is already the exclusive EU electronic vigilance channel solely because Actor/UDI modules are mandatory.

Module 6 — Market surveillance (mandatory since 28 May 2026)

Supports competent authorities (and the Commission) in market surveillance coordination. Commission materials describe this module as mandatory since 28 May 2026 for the Competent Authorities and the European Commission — manufacturers should still understand that surveillance activity is now operating inside the EUDAMED framework.

First mandatory set (Decision (EU) 2025/2371): Modules 1, 2, 3, and 6 — not Modules 4 and 5.

Legal Trigger: Decision (EU) 2025/2371 and the Six-Month Clock

On 26 November 2025, the Commission adopted Decision (EU) 2025/2371, published in the OJEU on 27 November 2025. That decision is the formal notice that the first four modules meet the functional specifications.

Under the gradual roll-out amendments in Regulation (EU) 2024/1860, obligations tied to a module generally become applicable six months after publication of the functionality notice. Counting from the OJEU publication in late November 2025 lands on 28 May 2026 — the date the Commission and national authorities now treat as the mandatory-use date for those four modules.

Why this matters: “EUDAMED is delayed” is no longer a planning assumption for Actor, UDI/Device, NB/Certificates, or Market Surveillance. Planning should assume enforcement-ready use of those modules.

Device Registration Timing: 28 May 2026 vs 28 November 2026

Commission materials and the practical gradual-roll-out Q&A distinguish when a device must be registered based on placement on the market. Industry guidance consistent with that framework commonly summarizes:

Situation	Typical registration expectation
Regulation device first placed on the EU market on/after 28 May 2026	Register in the UDI/Device module before the first individual unit is placed on the market (from the mandatory-use date)
Legacy or Regulation device placed on the EU market before 28 May 2026 and also placed on the market from 28 May 2026	Register within the transition window ending 28 November 2026 (six months after mandatory use start), per gradual roll-out logic under Regulation (EU) 2024/1860 / Commission materials
Devices no longer placed on the market from 28 May 2026	Often no full registration required solely for historical stock — unless a post-market surveillance or vigilance action requires registration (see Commission/Q&A rules on PMSV-triggered registration)

Legacy devices (devices under the Directives transitional regimes, as defined in MDCG guidance and MDR/IVDR transitional provisions) have specific identification formats in EUDAMED (including legacy device identifier handling). Use the Commission’s legacy-device management materials and current MDCG guidance when coding these products — do not invent DIY UDI structures.

If your portfolio mixes MDR-certified devices, IVDR devices, and legacy certificates with extended transition dates, build a SKU-level matrix: regulatory basis, first placement date, still-on-market flag, Basic UDI-DI readiness, AR/SRN ownership, and registration owner.

How Manufacturers Should Work EUDAMED (Practical Sequence)

1. Confirm actor registration for every legal entity that must hold an SRN (manufacturer, AR, importer as applicable). Validate contact data and role relationships.
2. Stabilize UDI data model — Basic UDI-DI strategy, UDI-DI assignment, labeling, and EUDAMED field mapping (including systems and procedure packs).
3. Register devices on the correct clock — new placements immediately under the May 2026 rule; clean up already-placed portfolio toward the November 2026 legacy/already-placed deadline.
4. Reconcile certificates with the Notified Bodies & Certificates module (your NB may enter certificate data; manufacturers still need internal tracking of what is live and public).
5. Update QMS / regulatory procedures — registration SOPs, change control when device data changes, AR agreements, and management review metrics for EUDAMED completeness.
6. Watch for SS(C)P and other data-service features — Commission communications in 2026 continue to add operational detail (for example SSCP/SSP-related functionality and training). Treat EUDAMED as a living system, not a one-time upload.

Authorized representatives for non-EU manufacturers should treat EUDAMED completeness as a shared liability and contractual topic: who enters data, who verifies, who updates when labels or certificates change, and how quickly.

Public vs Restricted Data (Competitive and Compliance Use)

Not all EUDAMED content is public. In general:

• More public: selected device identification information, certain certificate status information, and other transparency fields as released on the public site
• Restricted: competent authority / Notified Body workflows, detailed surveillance content, and (when live) detailed vigilance case data as applicable

Public EUDAMED data is increasingly useful for competitive intelligence (new entrants, certificate changes) and for due diligence (M&A, distributor onboarding). It is not a substitute for your own regulatory file.

Common Failure Modes in 2026

• SRN gaps — device registration blocked or inconsistent because actor data is incomplete
• Wrong assumption that “all six modules are mandatory” — teams invent vigilance processes that do not match the actual module status
• Portfolio dump without placement-date logic — missing the May vs November distinction
• Label / EUDAMED mismatch — UDI on-pack does not match registered data
• AR / manufacturer dual entry conflicts — unclear data ownership
• Ignoring Commission updates after May 2026 — new fields, SS(C)P workflows, and later module notices will keep coming

Staying Ahead of EUDAMED Changes

Even after the May 2026 mandate, EUDAMED is not static. The Commission publishes roadmap updates, Q&A revisions, training sessions, and — eventually — functionality notices for Vigilance and Clinical Investigations modules that will start new six-month clocks.

Regulatory Intelligence for EU market access should include:

• Commission EUDAMED news and guidance
• MDCG documents affecting registration and economic operators
• Notified body capacity and certificate status changes
• National competent authority enforcement notices related to EUDAMED non-registration

MedFlux monitors EU Commission and MDR/IVDR-related publications alongside 26 other regulators so RA teams see EUDAMED and broader EU device rule changes in one workflow — next to practical cluster content on EU MDR vs MDD and the MDD to MDR transition.

Frequently Asked Questions

When did EUDAMED become mandatory?

The first four modules became mandatory to use on 28 May 2026, following Commission Decision (EU) 2025/2371 (functionality notice) and the six-month transition under Regulation (EU) 2024/1860.

Which EUDAMED modules are mandatory now?

Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance. Clinical Investigations & Performance Studies and PMS and vigilance were not part of that first mandatory set.

What is Decision (EU) 2025/2371?

It is the Commission decision (26 November 2025; OJEU 27 November 2025) declaring that the first four EUDAMED modules meet the functional specifications — the formal trigger for the mandatory-use transition period.

Do legacy devices need EUDAMED registration?

If legacy (or already-placed Regulation) devices continue to be placed on the market after the mandatory-use start, registration is generally expected by 28 November 2026 under the common six-month portfolio rule described in Commission gradual-roll-out materials and industry guidance. Devices no longer placed on the market may have different treatment unless a PMS/vigilance action requires registration. Confirm against current Commission Q&A for your device category.

Is vigilance reporting already mandatory in EUDAMED?

The Vigilance and Post-Market Surveillance module was not among the four modules declared functional for the 28 May 2026 mandate. Continue to follow the MDR/IVDR transitional rules and competent authority instructions until that module’s own functionality notice and transition period apply.

What is an SRN?

The Single Registration Number assigned when an economic operator registers in the Actor module. It identifies the organization across EUDAMED processes.

Primary Sources

• European Commission — EUDAMED overview: mandatory modules as of 28 May 2026
• Commission Decision (EU) 2025/2371 (OJEU 27 November 2025)
• Regulation (EU) 2024/1860 (gradual roll-out of EUDAMED and related amendments)
• Regulation (EU) 2017/745 (MDR) and 2017/746 (IVDR)
• Commission Implementing Regulation (EU) 2021/2078 (detailed arrangements for EUDAMED)
• Commission Q&A on gradual roll-out of EUDAMED pursuant to MDR/IVDR as amended by Regulation (EU) 2024/1860

Related Resources

• EU MDR vs MDD: 12 Key Changes — Broader MDR context
• MDD to MDR Transition Guide — Portfolio and NB transition roadmap
• EMA / EU Regulatory Intelligence — EU hub on MedFlux
• FDA vs EMA Approval Process — US vs EU pathway comparison
• Glossary: EUDAMED | EU MDR | UDI | SRN | Authorized Representative