EUDAMED Mandatory Registration from May 28, 2026: Actor Registration, UDI/Device Module, Certificate Linkage, Market Surveillance, and What Medical Device and IVD Manufacturers Must Do Now

EUDAMED Is Now Mandatory: What the May 28, 2026 Deadline Means

On November 27, 2025, the European Commission published Commission Decision (EU) 2025/2371 confirming that four EUDAMED modules are fully functional and meet their legal specifications. Six months later, on May 28, 2026, the mandatory use period began.

This is not a soft launch or a transition period. From May 28, 2026, EUDAMED is the legally required database for registering economic operators, devices, certificates, and market surveillance data in the European Union. National registration systems are no longer sufficient. If a device is not in EUDAMED, it should not be placed on the market.

EUDAMED serves as the central digital infrastructure for EU MDR (Regulation 2017/745) and IVDR (Regulation 2017/746) compliance. It enables end-to-end device traceability, real-time regulatory oversight, and enhanced transparency across the product lifecycle.

Key Dates

What Becomes Mandatory on May 28, 2026

Four EUDAMED modules transition from voluntary to mandatory use:

1. Actor Registration Module (ACT)

All economic operators must register and obtain a Single Registration Number (SRN). This is the prerequisite for every other EUDAMED activity.

Who must register:

• Manufacturers (MDR and IVDR)
• Authorized Representatives (EC Rep)
• Importers
• System and Procedure Pack (S/PP) Producers
• Sponsors of clinical investigations and performance studies

The SRN is non-negotiable. No SRN means no device registration, no certificate linkage, and no EU market access. The SRN is the unique identifier that links your organization, role, and devices throughout the EUDAMED ecosystem.

2. UDI/Device Registration Module

Manufacturers and S/PP producers must register their devices in EUDAMED before placing them on the EU market.

Required data elements include:

• Basic UDI-DI
• All relevant UDI-DI(s)
• Risk class
• Intended purpose
• Storage and handling conditions
• Critical warnings
• Catalogue number
• EMDN code (must use the most specific terminal code available)

Manufacturers bear sole responsibility for consistency between EUDAMED data and their labeling, Instructions for Use (IFU), and technical documentation. Inconsistencies can delay certification, surveillance actions, or authority communications.

3. Notified Bodies and Certificates Module (NB/CRF)

Notified Bodies upload certificate data to EUDAMED. Manufacturers must ensure their Basic UDI-DI is registered and correctly linked to relevant certificates before the Notified Body can complete certificate upload.

This module creates public visibility into the certification status of CE-marked devices, enhancing transparency for regulators, healthcare providers, and patients.

4. Market Surveillance Module (MSU)

Competent authorities use this module for post-market surveillance, vigilance reporting, and enforcement actions. While manufacturers do not directly upload data to MSU, the device and certificate data they register feeds the surveillance infrastructure.

Who Must Register, and by When

Actor Registration Deadlines

Device Registration Deadlines

The November 2026 legacy device deadline does not apply if devices are subject to vigilance actions, incidents, or field safety corrective actions. For those devices, immediate registration is strongly recommended.

The SRN: Single Registration Number

The SRN is the foundation of EUDAMED. Without it, nothing else works.

How to Obtain an SRN

1. Register in the Actor module with your organization's details
2. Your Authorized Representative (if applicable) verifies the registration
3. Your Competent Authority validates and approves the registration
4. EUDAMED issues the SRN — a unique alphanumeric code identifying your organization and role

SRN Structure

The SRN follows a specific format:

• Country code (2 characters) — the EU member state where the actor is established
• Actor role code (1 character) — identifying the economic operator type
• Organization identifier (9 characters) — unique to the actor

Common SRN Delays

Competent Authority approval times vary by country. Some member states process SRN applications within days; others may take weeks. Manufacturers should initiate Actor Registration well in advance of their planned device registration.

Distributors (as distinct from importers) do not need to register in EUDAMED. This distinction is important: an importer is defined under MDR Article 2(33) as any natural or legal person established within the EU that places a device from a third country on the EU market. A distributor, defined under Article 2(34), makes a device available on the market after it has already been placed on the market.

UDI/Device Registration: Data Requirements

The UDI/Device Registration Module requires structured, accurate data for every device placed on the EU market. This is where most manufacturers encounter the most complexity.

Basic UDI-DI

The Basic UDI-DI is the primary identifier for a device group. It links to the relevant certificates and technical documentation. Key points:

• The system allows registration of the Basic UDI-DI during the conformity assessment process — before the certificate is finalized
• Each Basic UDI-DI must be unique and correctly assigned per the UDI rules in MDR Annex VI
• For legacy and MDR/IVDR devices with linked codes, the database allows linking an MDR/IVDR-compliant device to its corresponding legacy device

UDI-DI Data Elements

Manufacturers must provide the following for each UDI-DI:

EMDN Code Requirements

The updated EMDN FAQ (MDCG 2021-12 Rev.2, April 2026) now explicitly requires manufacturers to select the most specific (terminal) EMDN code available. Using more than one code is only acceptable in limited, justified cases, such as complex systems with multiple intended purposes.

The FAQ also introduces EMDN lifecycle management: codes may change, be split, or become obsolete through annual revisions. Manufacturers must monitor EUDAMED for EMDN updates and adjust their registrations accordingly.

Data Quality: The Real Challenge

Most manufacturers understand that they need to register. The harder problem is the data quality required to do so correctly. EUDAMED demands:

• Clean, structured UDI codes for every device in the portfolio
• Accurate lot numbers and device identifiers
• Real-time linkage between physical inventory and registered device records
• Consistency across EUDAMED, technical documentation, labeling, IFU, and certificates

For manufacturers with large device portfolios, auditing and preparing this data can take months. Common issues include:

• UDI-DIs assigned under the old directives that do not match MDR requirements
• EMDN codes at too general a level
• Inconsistent risk classifications between legacy and MDR devices
• Missing or inaccurate catalog numbers

Certificate Linkage: How Notified Bodies Fit In

The Notified Bodies and Certificates module creates a direct link between device registrations and conformity assessment certificates. The workflow:

1. Manufacturer registers the Basic UDI-DI and device data in the UDI/Device module
2. Notified Body uploads the relevant certificate information
3. EUDAMED links the certificate to the registered device data
4. The linked record becomes the public-facing evidence of CE marking compliance

Manufacturers must ensure their Basic UDI-DI is registered and correctly matches their certificate data before the Notified Body attempts to upload. Misalignment between device data and certificate details can block the linkage and delay the registration process.

For legacy certificates, Notified Bodies have until May 28, 2027 (18 months from the mandatory use date) to upload certificate information.

Legacy Device Transition Rules

Legacy devices — those placed on the EU market before May 28, 2026 that will continue to be placed on the market after that date — have special transition provisions:

Registration Deadline

Legacy devices must be registered in EUDAMED by November 27, 2026 (six months after mandatory use begins). However, this derogation does not apply if devices are subject to:

• Vigilance actions
• Incidents
• Field Safety Corrective Actions (FSCA)

For these devices, immediate registration is required.

Practical Approach

Notified bodies and regulatory consultants (including DNV) recommend a practical approach for legacy devices:

1. Triage your portfolio: Separate MDR/IVDR devices from legacy devices
2. Map existing UDI-DIs: Identify which legacy devices already have UDI-DIs assigned
3. Prepare structured data: Format legacy device data for EUDAMED upload
4. Prioritize high-risk devices: Register Class III and implantable legacy devices first
5. Use bulk upload where available: EUDAMED supports structured bulk upload for large portfolios

Legacy Device Linking

The database allows linking an MDR/IVDR-compliant device to its corresponding legacy device. If a UDI-DI has already been assigned to the legacy device, it must be entered during registration.

Swissdamed: Parallel Registration in Switzerland

Switzerland is implementing its own device registration database, swissdamed, with registration requirements starting July 2026. Manufacturers marketing devices in both the EU and Switzerland must register in both EUDAMED and swissdamed.

Key differences:

• Swissdamed registration begins July 1, 2026
• Device registration fees in Switzerland are expected to start in July 2026 (exact fees pending)
• Swiss CH-Rep registration requirements mirror but are separate from EU EC Rep requirements

What Happens If You Don't Comply

EUDAMED registration is a legal requirement under MDR Article 29 (device registration) and Article 31 (economic operator registration). Non-compliance carries several consequences:

Market Access Risk

From May 28, 2026, devices not registered in EUDAMED should not be placed on the EU market. National competent authorities are expected to enforce this requirement, and non-registered devices may be subject to:

• Market withdrawal
• Import holds at customs
• Enforcement actions by competent authorities

Vigilance and Recall Complications

Without EUDAMED registration, manufacturers cannot effectively participate in the EU's vigilance and market surveillance system. This creates regulatory risk:

• Incidents cannot be properly reported and tracked
• Field Safety Corrective Actions cannot be linked to device records
• Competent authorities cannot verify device compliance status

Notified Body Implications

Notified Bodies cannot upload certificate data for devices that are not registered in EUDAMED. This creates a circular dependency: no registration means no certificate linkage, which may delay or prevent conformity assessment completion.

Step-by-Step Action Plan for Manufacturers

If You Haven't Started

1. Request Actor Registration immediately — obtain your SRN
2. Audit your device portfolio — identify every device that needs registration
3. Map your UDI-DIs — ensure every device has a valid Basic UDI-DI and UDI-DI
4. Verify EMDN codes — ensure you are using the most specific terminal codes
5. Coordinate with your Authorized Representative — they must verify your actor registration
6. Coordinate with your Notified Body — confirm the timeline for certificate uploads
7. Prepare data for bulk upload — use structured templates for large portfolios

If You've Started but Haven't Completed

1. Prioritize new-to-market devices — these cannot be placed on the market without registration
2. Complete legacy device registration — target the November 27, 2026 deadline
3. Verify data consistency — cross-check EUDAMED data against labeling, IFU, and certificates
4. Test certificate linkage — confirm that your Notified Body can link to your registered devices

If You Are an Authorized Representative

1. Complete Actor Registration — obtain your SRN
2. Verify manufacturer registrations — confirm that all manufacturers you represent have registered
3. Update your status — your registration status is now publicly visible in real time in EUDAMED

If You Are an Importer

1. Register as an Actor — obtain your SRN
2. Link to registered devices — once manufacturers have registered their devices, you must link your importer role to those devices
3. Monitor for new device registrations — ensure you are linked to all devices you import

Modules Not Yet Mandatory

Two EUDAMED modules are not yet confirmed as functional and remain voluntary:

• Clinical Investigations and Performance Studies — expected to become mandatory in a future Commission Decision
• Vigilance and Post-Market Surveillance — separate from the Market Surveillance module, this will handle incident reporting and FSCA

Manufacturers should continue using existing national vigilance systems for these activities until the corresponding EUDAMED modules become mandatory.

Key Takeaways

• May 28, 2026 was the deadline. EUDAMED is now mandatory for Actor Registration, UDI/Device Registration, NB/Certificates, and Market Surveillance.
• No SRN = no market access. Obtain your Single Registration Number before anything else.
• New devices must be registered before market placement. No registration, no EU market access.
• Legacy devices have until November 27, 2026. But devices subject to vigilance actions need immediate registration.
• Data quality is the real challenge. Audit your UDI-DIs, EMDN codes, and portfolio data before uploading.
• National registration systems are no longer sufficient. EUDAMED is now the single required registration system for the EU.
• Coordinate with your Notified Body. Certificate linkage requires both manufacturer registration and NB upload.
• Switzerland has its own system (swissdamed). Separate registration starting July 2026.