EUDAMED Countdown: A 5-Month Data Sprint for Compliance

As most of you know, the clock has officially started ticking. On November 27, 2025, the European Commission published the long-awaited Official Journal notice declaring the full functionality of the first four EUDAMED modules. This triggered a rigid six-month transition period that ends on May 28, 2026.

Medical device manufacturers, this date is no longer a tentative target on a shifting roadmap. It is a hard regulatory wall. If you are reading this in January, you do not have six months. You have barely five.

This “5-month data sprint” is not just about submitting forms. It is about validating thousands of data points, ensuring your Single Registration Number (SRN) is active, and guaranteeing that every new device placed on the EU market after May 28 has a compliant digital footprint. The time for “wait and see” is over. The time for execution is now.

The May 28 Milestone: What Actually Changes?

It is vital to understand exactly what becomes mandatory in May. The European Commission has taken a modular approach, and while some elements have been available for voluntary use, they become legally binding obligations on this date.

1. Actor Registration is Mandatory

Every economic operator (Manufacturer, Authorized Representative, Importer, and System/Procedure Pack Producer) must be registered in EUDAMED and hold a valid SRN. Without an SRN, you cannot register devices, and without registered devices, you cannot legally sell them.

2. New Devices Must Be Registered

Any new device placed on the market after May 28, 2026, must be registered in the EUDAMED UDI/Device module before it enters the supply chain. There is no grace period for new product launches. If the data isn’t in the system, the product stays in the warehouse.

3. Notified Bodies and Certificates

Your Notified Body will be required to upload certificates and Summary of Safety and Clinical Performance (SSCP) documents directly into the system. If your device data does not perfectly match the data on their certificates, the system will flag discrepancies, potentially stalling your market access.

Why 5 Months is a “Sprint”

You might think five months is plenty of time. In the world of regulatory data, it is a blink of an eye. The volume of data required for EUDAMED is significantly higher than what was required for the old MDD/IVDD compliance or even for the US FDA’s GUDID.

A single device registration can involve over 100 data attributes. Multiply that by your number of SKUs, and you are looking at thousands of fields that need to be sourced, cleaned, validated, and formatted.

The “Hidden” Time Drains:

• Data Sourcing: Your regulatory data likely lives in silos—some in ERP systems, some in PLM software, and too much of it in scattered Excel spreadsheets or PDFs. Consolidating this into a “single source of truth” takes weeks.
• Validation Errors: EUDAMED’s validation rules are strict. A simple formatting error in a Basic UDI-DI code or a mismatch in the “Risk Class” field can cause a bulk upload to fail entirely.
• SRN Delays: Obtaining your SRN requires validation by a Competent Authority. In some member states, this manual approval process can take weeks, especially as a backlog forms closer to the deadline.

The Hurdle: Basic UDI-DI vs. UDI-DI

One of the most common stumbling blocks we see during this sprint is the confusion between the Basic UDI-DI and the UDI-DI.

The UDI-DI is the specific identifier (usually a GTIN) found on the physical label of your device. It identifies the specific product unit or package.

The Basic UDI-DI is a purely administrative code. It never appears on the label or the device itself. Instead, it groups devices with the same intended purpose, risk class, and essential design characteristics. It is the primary key in the EUDAMED database that links your devices to your technical documentation and certificates.

The Trap: Many manufacturers rush to upload their GTINs (UDI-DIs) without first correctly establishing their Basic UDI-DI groups. EUDAMED requires the Basic UDI-DI to be created first. If your grouping strategy is flawed, you may have to delete records and start over, wasting precious time during the sprint.

Legacy Devices: The “Soft” Deadline Trap

While the May 28 deadline is hard for new devices, “legacy” devices (those already on the market under MDD/IVDD certificates) have a slightly different timeline. They generally must be registered by November 2026 (12 months after the notice).

Do not let this full you into a false sense of security.

If you plan to sell a legacy device after May 2026, you still need your Actor registration (SRN) in place by May. Furthermore, if a legacy device undergoes a significant change that triggers a new MDR certificate, it immediately becomes a “new” device subject to the May deadline. Mixing up these timelines is a recipe for compliance gaps. The safest strategy is to treat your entire active portfolio as a priority for the May sprint.

Your 5-Month Action Plan

To survive this sprint and cross the finish line with your market access intact, you need a structured approach.

Month 1: Verification and Gap Analysis

• Check your SRN: Log in to EUDAMED today. Is your status “Valid”? If you are an Importer or Authorized Representative, ensure your links to manufacturers are confirmed.
• Map your Portfolio: Identify exactly which devices will be “new” introductions after May 28 and which are legacy. Prioritize the new ones.
• Audit your Data: Run a sample of your device data against EUDAMED’s specifications. Do you have the GMDN/EMDN codes assigned? Are your Basic UDI-DIs correctly formulated with the check digit?

Month 2-3: Data Cleaning and Aggregation

• Centralize Data: Move data out of spreadsheets and into a structured management system if possible.
• Fix the Gaps: Fill in the missing mandatory attributes. Pay special attention to “Container Package” details and “Storage/Handling” conditions, which are often missing from standard ERP data.
• Validate Basic UDI-DIs: Ensure every single SKU is mapped to the correct Basic UDI-DI parent.

Month 4: Testing and Submission

• Use the Playground: EUDAMED offers a “Playground” (testing) environment. Use it. Try uploading your XML files or manual entries here first. If they fail, you want them to fail in the sandbox, not the production system.
• Machine-to-Machine (M2M) Setup: If you have a large portfolio, manual entry is impossible. Ensure your M2M connection is configured and authenticated. This technical setup can take weeks to troubleshoot with IT teams.

Month 5: Final Review and Go-Live

• Upload to Production: Begin submitting your validated data to the live EUDAMED production environment.
• Monitor Status: “Submitted” does not always mean “Registered.” Watch for feedback messages.
• Link Certificates: Work with your Notified Body to ensure they see your registered Basic UDI-DIs so they can link the certificates.

Conclusion: The Cost of Inaction

The May 28 deadline is a binary event. On May 29, the system is either mandatory for you, or you are non-compliant. The European Commission has signaled that the time for delays and extensions is over. Market surveillance authorities will be using this database to monitor compliance, and the absence of your data will be an immediate red flag.

This 5-month sprint is demanding, but it is achievable with the right focus and tools. The goal is not just to “feed the beast” of the database but to build a sustainable data process that keeps your devices on the market and available to the patients who need them.

Don’t let data complexity become a barrier to your market access. If you are feeling the pressure of the countdown or need assistance navigating the complexities of UDI, legacy device management, or M2M connectivity, expert help is available.

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