EUDAMED Becomes Fully Mandatory from 28 May 2026: What Medical Device & IVD Manufacturers Need to Know

The European Commission has confirmed a major milestone for the medical devices and IVD industry. On November 27, 2025, the Commission published Commission Decision (EU) 2025/2371 in the Official Journal of the European Union (OJEU), formally validating four fully functional modules of the European Database on Medical Devices (EUDAMED).

This development activates the ‘gradual roll-out’ provisions introduced by Regulation (EU) 2024/1860 and sets the date for mandatory EUDAMED use on 28 May 2026, exactly six months from its publication.

For manufacturers, authorized representatives, importers, and Notified Bodies, this marks one of the most significant regulatory developments since the introduction of the EU MDR and IVDR. The update provides long-awaited clarity about compliance timelines and reinforces the EU’s commitment to transparency, traceability, and post-market oversight.

Organisations that have not begun uploading their UDI and device data have a very tight window of less than 6 months to prepare, validate, and upload huge datasets into the EUDAMED database.

What the Announcement Means for Industry

The Commission’s publication confirms that four out of the six EUDAMED modules meet the functional requirements set out in the MDR and IVDR:

• Actor Registration
• UDI & Device Registration
• Notified Bodies & Certificates
• Market Surveillance

This validation triggers Article 123(3) MDR transitional provisions, introducing fixed deadlines for mandatory use. From May 28, 2026, economic operators across the EU must shift from optional to required EUDAMED participation.

The Legacy Device registration deadline is November 27, 2026.

According to Article 10a (effective January 2025) introduced by Regulation (EU) 2024/1860, manufacturers must notify authorities, economic operators, and health institutions of any interruption or discontinuation of supply that could result in serious harm. Failure to notify about an unavailable device registered as ‘On the Market’ in EUDAMED may lead to double liability for the manufacturer.

With EUDAMED becoming the central regulatory data source, it is essential for stakeholders to prepare early. User Interface (UI) challenges or operational issues will no longer justify delaying compliance.

Which EUDAMED Modules are Officially Functional?

The Commission has confirmed the operational readiness of the following modules:

1. Actor Registration (Art. 30 MDR / Art. 27 IVDR)

   This module issues the Single Registration Number (SRN) for all economic operators. The SRN is the digital identity for any regulatory activity within the EU, including conformity assessment applications and device registration. Manufacturers, authorised representatives (ARs), importers, system/procedure pack producers (SPPPs), and clinical investigation sponsors must submit organizational, and PRRC information to the portal. National Competent Authorities (CAs) validate submissions, and a surge in registrations may create backlogs. Delayed SRN issuance will block device registrations and market access. Non-EU manufacturers need verification from ARs before CAs and must ensure that the digital linkage to their AR is valid. Termination of AR’s contract will be immediately visible to the market and authorities.

2. UDI & Device Registration (Art. 28–29 MDR / Art. 25–26 IVDR)

   This is the most resource-intensive module. Manufacturers and SPPPs must enter every medical device and IVD for sale in the EU market into the portal, using the Unique Device Identification (UDI) system. All devices must be registered in EUDAMED before being placed on the EU market from 28 May 2026. New device launches from May 2026 must consider EUDAMED data entry timelines.

3. Key concepts:

   • Basic UDI-DI (BUDI-DI) is the primary key grouping devices with the same intended purpose, risk class, and essential design characteristics.
   • BUDI-DI is also the link to certificates and vigilance records and therefore, care must be taken when grouping devices under a BUDI-DI.
   • BUDI-DI is distinct from the UDI-DI, which is the GTIN on the device package.
   • Existing product families must be uploaded by 27 November 2026 to maintain current UDI-DI structures.
   • EUDAMED has a restricted site and a public site. The public site will display most of the device data, including the intended purpose, warnings and CMR substances. Marketing claims must align with EUDAMED entries perfectly to prevent misbranding allegations.
   • Manufacturers with large portfolios should evaluate Machine-to-Machine (M2M) solutions to integrate ERP/PLM systems directly with EUDAMED via XML-based protocols.

4. Notified Bodies & Certificates (Art. 57 MDR / Art. 52 IVDR)

   This module centralizes all certificate information under MDR and IVDR. NBs are obligated to register granted, refused, withdrawn, or suspended certificates. Refused applications will be visible to all NBs, requiring manufacturers to disclose prior failures. NBs must upload certificates issued prior to the mandatory date by May 28, 2027. During the interim, manufacturers should maintain accessible copies for distributors or importers.

5. Market Surveillance (Art. 100 MDR / Art. 95 IVDR)

   This module is accessible only to Competent Authorities and supports coordination of inspections, enforcement actions, non-compliance reports, and public health protection measures. A report filed by any Member State becomes instantly visible across the EU.

Mandatory Use Begins 28 May 2026

All economic operators must complete Actor Registration and obtain an SRN before 28 May 2026. This includes:

• Manufacturers
• Authorised Representatives (ARs)
• Importers
• System and procedure pack producers (SPPPs)
• Clinical investigation sponsors

Without an SRN, no regulatory activity in EUDAMED can proceed. This transition will be especially demanding for manufacturers with extensive portfolios or multi-country distribution networks within the EU.

What’s Still Pending?

Two modules remain under development:

• Module 4: Clinical Investigations Module: For reporting and managing clinical studies carried out under MDR.
• Module 5: Vigilance Module: For reporting serious incidents, Field Safety Corrective Actions (FSCAs), and trends. Until the module becomes functional, manufacturers must continue reporting directly to national Competent Authorities.

Once these modules are deemed fully functional, the Commission will determine the date for mandatory use of the complete EUDAMED system.

Until then, the industry should assume that timelines will accelerate and not slow down.

Legacy Device Registration

Legacy devices intended to remain on the market after November 2026 must be registered within 12 months of the functionality notice. For these devices, a EUDAMED-DI (EUDAMED Device Identifier) and a EUDAMED-ID (instead of the BUDI-DI) must be generated.

Given that legacy devices constitute the majority of many portfolios, the data volume will be significant. Early preparation will be critical to avoid congestion and system delays. However, the devices to be launched must be prioritised over the ones already in the market.

How Manufacturers Should Prepare now

With less than two years remaining, organizations should begin structured implementation:

• Validate internal UDI data for accuracy and completeness.
• Ensure organisational details, PRRC information, and hierarchies are updated.
• Register new MDR/IVDR devices on priority to prevent launch delays post-May 2026.
• Identify legacy devices that will remain on the market past November 2026 and initiate their EUDAMED-DI creation.
• Align PMS, vigilance, and QMS procedures with EUDAMED outputs.
• Confirm timelines for uploading certificates with NBs.
• Plan for long-term digital strategies. Manual processes will not scale once EUDAMED becomes fully operational.

Starting early will reduce pressure and prevent last-minute compliance risks.

How Celegence Can Support Your EUDAMED Readiness

Celegence supports medical device and IVD manufacturers with regulatory consulting and technology-enabled services designed to help navigate evolving EU MDR/IVDR environment. Our teams assist with:

• Actor registration and SRN preparation
• UDI-DI and Basic UDI-DI mapping
• EUDAMED data preparation, validation and entry
• Portfolio-wide device registration strategies
• EU MDR and IVDR regulatory transition planning
• PMS and PMCF documentation alignment

With CAPTIS^®, our AI-enabled regulatory authoring platform, we help streamline documentation, improve data consistency, and support end-to-end readiness for the 2026 EUDAMED transition.

If you need guidance preparing for your EUDAMED planning, contact us at info@celegence.com.