EUDAMED’s UDI / Product Module Is Approved

Why This Is A Turning Point for

EU MDR Compliance

After years of phased development, uncertainty, and voluntary use, a critical milestone in the European Union Medical Device (EU MDR) implementation is now official.

Following a successful independent audit, the European Database on Medical Devices (EUDAMED) UDI/Products module has been formally approved, with the European Commission’s decision published in the EU Official Journal. This approval does more than validate functionality. It activates legally enforceable obligations for manufacturers placing medical devices on the EU market.

For companies with products in the European Union, the question is no longer whether EUDAMED UDI registration applies. The real question is how prepared your organization is to execute accurately and at scale.

What Was Approved and Why It Matters

EUDAMED was designed as the central digital backbone of the EU MDR and IVDR frameworks, providing regulators and stakeholders with a unified view of a device’s lifecycle, from manufacturer and UDI assignment through certification, vigilance, and market surveillance.

Each EUDAMED module must undergo independent verification before becoming mandatory. The approval of the UDI/Products module confirms that it now meets the EU’s functional requirements and is ready for mandatory use.

With the publication of this decision, UDI and product registration requirements move from transitional theory to enforceable reality. Fixed timelines now apply, and manufacturers are expected to comply regardless of company size or device classification.

For many organizations, this marks the moment when EUDAMED shifts from a background regulatory topic to a front-line operational priority.

The Compliance Timeline

The approval triggers two critical milestones that manufacturers need to plan around now.

28 May 2026

Six months after approval – For New Devices

By this date, products with a specific UDI-DI that have not previously been placed on the EU market must be registered in EUDAMED, with the mandatory use of the first four modules:

1. 1. Actor Registration,

   2. UDI/Devices Registration,

   3. Notified Bodies and Certificates,

   4. Market Surveillance

28 November 2026

Twelve months after approval – For Legacy Devices

By this date, products with a specific UDI-DI that were already on the EU market must be registered in EUDAMED.

How to interpret this:

• New products or variants introduced after 28 November 2025 must be registered with the mandatory use of the first four modules by May 28, 2026

• Existing products or variants already on the market must be registered no later than November 28, 2026

These timelines are fixed. There is no grace period once mandatory use begins.

Who Will Be Impacted?

While all MDR manufacturers are in scope, EUDAMED UDI registration will be especially challenging for organizations with:

• Large or highly variant product portfolios

• Legacy devices alongside MDR-certified products

• Software or SaMD products with frequent updates

• Decentralized ownership of UDI and product data

For these companies, EUDAMED registration is not a one-time submission. It becomes an ongoing data governance and change-management discipline.

Manual vs. Machine-to-Machine Registration as a Strategic Decision 

Manufacturers must also decide how they will register and maintain their data in EUDAMED.

Manual entry may be feasible if you have:

• A small number of devices or variants

• Infrequent UDI-related updates

• Dedicated internal resources for ongoing maintenance

Machine-to-machine integration is often necessary if you have:

• Large or frequently changing portfolios

• Multiple internal data sources feeding UDI information

• Existing UDI management embedded in ERP or PLM systems

  
  

The Importance of Local Actor Administrators

EUDAMED requires organizations to maintain at least two Local Actor Administrators. This requirement is more than an administrative checkbox.

Local Actor Administrators control access to:

• Initial registrations
• Data corrections
• Product updates and lifecycle changes

Without redundancy, organizations risk losing system access during staff turnover, extended leave, or role changes. That loss of access can delay registrations or corrections at precisely the wrong time, particularly as regulatory deadlines approach. Effective EUDAMED readiness includes continuity planning, not just account creation.

What Manufacturers Can Do to Prepare Now

With enforceable timelines in place, preparation should already be underway. Practical next steps include:

• Mapping product and variant portfolios to Basic UDI-DI structures
• Validating UDI data accuracy and internal ownership
• Assessing manual versus machine-to-machine registration feasibility
• Confirming Local Actor Administrator coverage and governance procedures
• Familiarizing teams with EUDAMED workflows and interfaces

Organizations that treat this as a structured compliance and data-governance initiative, rather than a last-minute upload exercise, will be far better positioned for mandatory use approaches.

Final Takeaway

The approval of the EUDAMED UDI/Products module marks a clear turning point in EU MDR implementation. The period of regulatory uncertainty has ended. Execution now matters.

Manufacturers that invest early in data quality, governance, and registration strategy will reduce risk, avoid bottlenecks, and maintain control over EU market access. Those who wait may find themselves racing against immovable deadlines with limited options.

For teams unsure whether their UDI data, systems, or internal processes are truly ready, now is the right time to assess and correct the course before registration becomes urgent.