EUDAMED After Go-Live: What the First Weeks Reveal and What to Do Next

The Deadline Has Passed — Now the Real Work Begins

On May 28, 2026, EUDAMED stopped being a planning topic and became an operating requirement. The European Commission's Implementing Decision (EU) 2025/2371, published November 27, 2025, triggered the mandatory-use period for four modules: Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance.

MedTech Europe confirmed the milestone on June 4, 2026, noting that EUDAMED is now the central platform for regulatory information on medical devices and IVDs placed on the EU market. National registration systems are no longer sufficient on their own.

But mandatory does not mean complete. Industry reports and regulatory consultants working through the first weeks of mandatory EUDAMED report a familiar pattern: actor registrations that were started late, device data that does not match certificate records, and legacy device portfolios that still need triage.

This article covers what the post-go-live period actually looks like, the common compliance gaps surfacing in the first weeks, and the priority actions manufacturers should take between now and the November 2026 legacy device deadline.

Where Things Stand: The First Two Weeks

Actor Registration Is the Gatekeeper

Everything in EUDAMED starts with actor registration. Manufacturers, authorized representatives, importers, and system/procedure pack producers must have a verified Single Registration Number (SRN) before any device registration can proceed.

In practice, the actor registration process involves:

• Registering via the Actor module with full legal entity details
• Verification by the authorized representative (for non-EU manufacturers) and by the national competent authority
• Receiving the SRN, which becomes the permanent identifier for all EUDAMED transactions

Delays at the actor-registration stage cascade downstream. A manufacturer whose SRN is still pending cannot register devices, and a distributor who cannot confirm the importer registration cannot verify the supply chain.

New Device Registration Is Now a Pre-Market Gate

From May 28, 2026, any device, system, or procedure pack that is new to the EU market must be registered in EUDAMED's UDI/Device module before it is first placed on the market. This is a hard regulatory gate, not a post-market reporting obligation.

Manufacturers must provide:

• Basic UDI-DI
• All relevant UDI-DI(s) with device attributes
• Risk class and intended purpose
• EMDN code
• Information on which EU member states the device is marketed in
• Storage, handling, and critical warning information

For devices that require Notified Body involvement (Class IIb implantable, Class III, Class C near-patient IVD, Class D IVD), the registration is auto-routed to the Notified Body for certificate confirmation before publication in the public database.

Legacy Devices Have Until November 27, 2026

Devices that were lawfully placed on the EU market before May 28, 2026, and will continue to be placed on the market afterward, must be registered by November 27, 2026 — six months after the mandatory-use date.

This gives manufacturers a finite window to triage their legacy portfolios, prepare structured data, and complete bulk uploads. But the six-month clock is already running.

Common Compliance Gaps in the First Weeks

1. Data Mismatch Between Technical Documentation and EUDAMED Entries

DNV, a major Notified Body, has highlighted that data consistency is now a critical compliance requirement. All EUDAMED data must match the information in technical documentation, labeling, instructions for use, and certificates issued by the Notified Body.

Common mismatches include:

• Risk class discrepancies between the EUDAMED entry and the CE certificate
• Trade names or catalogue numbers that differ slightly from the IFU
• UDI-DI data elements that do not align with the information on the device label

Inconsistencies can delay certification, trigger surveillance actions, or prompt authority communications requiring correction.

2. Incomplete Actor Registration Chains

For non-EU manufacturers, the actor registration chain involves three parties: the manufacturer, the authorized representative, and the competent authority. Each must verify in sequence. If the authorized representative has not completed its own registration, the manufacturer's SRN cannot be finalized.

Registrar Corp notes that organizations with complex supply chains — multiple importers, authorized representatives in different member states, or system/procedure pack producers — face the most challenging registration coordination.

3. Bulk Upload Errors for Large Portfolios

Manufacturers with large device portfolios face a significant data challenge. Each EUDAMED device entry contains over 120 data fields, from risk class to critical components. XML bulk uploads offer efficiency, but a single formatting error can reject an entire file.

Registrar Corp reports that data integrity is the most significant hurdle for organizations with large portfolios. Consolidating and cleansing device data to meet EUDAMED's structured format requirements often exceeds the capability of internal IT departments that are not prepared for the task.

4. Notified Body Certificate Upload Timing

Notified Bodies are required to upload certificate information to EUDAMED, but the timing and process vary. Until a Notified Body has confirmed the certificate data linked to a device registration, the entry cannot be fully published. DNV has noted that it is implementing measures to meet the mandatory-use deadline and ensure timely submission.

For legacy certificates, Notified Bodies have until May 28, 2027, to complete uploads — a 12-month window from the mandatory-use date. But manufacturers cannot wait for NB uploads to start their device registrations.

What Is NOT Mandatory (Yet)

Two EUDAMED modules remain under development and are not part of the mandatory-use period:

• Vigilance and Post-Market Surveillance — expected to become mandatory in Q3 2026, subject to functionality confirmation
• Clinical Investigations and Performance Studies — timeline to be confirmed

When these modules become mandatory, they will trigger additional obligations for manufacturers conducting clinical investigations or reporting vigilance events. But there will be no voluntary-use period; they will become mandatory immediately upon declaration.

Six-Month Action Plan: June to November 2026

Priority 1: Complete Actor Registration (If Not Done)

If your organization does not yet have a verified SRN, this is the single most blocking issue. Steps:

1. Register via the EUDAMED Actor module with full legal entity details
2. Coordinate with your authorized representative for their verification
3. Follow up with the relevant competent authority for final confirmation
4. Record the SRN and distribute to all internal teams handling device registration

Priority 2: Register New Devices Before Market Entry

Any device that will be placed on the EU market for the first time after May 28, 2026, must be registered before distribution. Build EUDAMED registration into your product launch workflow:

1. Prepare the UDI-DI data package as part of the technical documentation
2. Verify that all data elements match the CE certificate and labeling
3. Submit the registration and, where applicable, wait for Notified Body confirmation
4. Confirm the registration is published before releasing the first sales unit

Priority 3: Triage Your Legacy Portfolio

The November 27, 2026, deadline for legacy device registration requires a structured approach:

1. Categorize your portfolio: Separate MDR/IVDR-certified devices from legacy devices (those still CE-marked under the old MDD/AIMDD/IVDD directives)
2. Map existing UDI-DIs: Identify which devices already have UDI-DI data and which need new assignments
3. Identify exemptions: Custom-made devices and devices that will no longer be placed on the market after May 28, 2026, do not require registration unless vigilance activities are necessary
4. Prepare bulk upload data: Use the EUDAMED XML schema to structure your legacy device data for efficient upload

Priority 4: Verify Data Consistency Across All Systems

EUDAMED data must be consistent with your technical documentation, labeling, and certificates. Conduct a cross-reference audit:

• Device risk class in EUDAMED matches the CE certificate
• Trade names, model numbers, and catalogue numbers are identical across EUDAMED, IFU, and product labeling
• UDI-DI data elements align with what is printed on the device label

Priority 5: Engage Your Notified Body

Coordinate with your Notified Body on certificate upload timing. Confirm:

• Which certificates need to be uploaded
• The NB's internal timeline for legacy certificate uploads
• Any data the NB needs from you to complete the linkage

Penalties for Non-Compliance

The consequences of missing EUDAMED obligations are material. MedEnvoy reports that non-compliance can trigger:

• Market access restrictions: Competent authorities can prohibit placement of non-compliant devices through enforcement actions and sales suspensions
• Supply chain disruptions: Distributors and importers require proof of EUDAMED compliance, creating operational bottlenecks
• Certificate processing delays: Notified Bodies may refuse new applications or renewals for manufacturers without completed actor registrations
• Financial penalties: Individual EU member states can impose regulatory penalties, in addition to lost revenue from market access restrictions

EUDAMED Is Free — But the Compliance Cost Is Real

EUDAMED registration itself is free of charge, unlike many government registration systems (FDA, TGA, HSA, and others charge fees). But the cost of compliance comes from data preparation, internal coordination, system integration, and the opportunity cost of delayed market access.

For organizations still working through their EUDAMED obligations, the priority is clear: complete actor registration, register all new devices before market entry, and use the next five months to triage and upload legacy device data before the November 27, 2026, deadline.

Sources

• European Commission, Commission Decision (EU) 2025/2371, November 27, 2025. Official Journal of the European Union.
• MedTech Europe, "EUDAMED Reaches a Major Milestone: Mandatory Use of the First Four Modules Begins," June 4, 2026.
• DNV, "EUDAMED Mandatory Use: What Manufacturers Need to Know," 2026.
• Registrar Corp, "EUDAMED Registration Deadlines 2026: A Mandatory Compliance Checklist," 2026.
• MedEnvoy, "What Is the May 2026 EUDAMED Deadline?" 2026.
• Sistemir, "Mandatory EUDAMED Registration from May 28, 2026," 2026.
• European Commission Directorate-General for Health and Food Safety, "EUDAMED UDI/Device Registration," 2026.