The Last Mile challenge in UDI when using ERP/PLM/QMS systems

In the medical device lifecycle, there is a paradox. We use sophisticated software to design products, advanced robotics to manufacture them, and state-of-the-art ERP systems to ship them. Yet, when it comes to the final critical step – notifying the regulators that the device exists – the industry largely reverts to the technological equivalent of the Stone Age: Excel spreadsheets and manual typing.

This is the “Last Mile” problem of Unique Device Identification (UDI).

As we navigate through 2026, the regulatory landscape has become too complex for manual data entry. With EUDAMED mandatory deadlines approaching, the FDA GUDID requiring constant maintenance, and new databases coming online in Australia, Brazil, and China, the manual “swivel chair” approach is no longer just inefficient. It is a compliance liability.

The solution lies in automation. Specifically, it lies in bridging the gap between your engineering source of truth – the Product Lifecycle Management (PLM) system – and the external regulatory databases.

The High Cost of the “Swivel Chair” Interface

For years, Regulatory Affairs professionals have acted as human middleware. The process typically looks like this:

1. Engineering finalizes a product change in the PLM/ERP/RIM/QMS systems.
2. Regulatory Affairs receives a notification (or discovers it in a meeting).
3. Someone extracts the data into a spreadsheet.
4. That person manually logs into the FDA GUDID or EUDAMED web portal.
5. They copy and paste values from the spreadsheet into the web form, one by one.

This process is fraught with danger. A typo in a sterility code, a mismatched Basic UDI-DI, or a forgotten dimension unit can trigger a rejection or, worse, a discrepancy between your physical label and the public database.

In 2026, the volume of data attributes required per device has exploded. We are not just talking about a GTIN and a description anymore. We are talking about clinical data summaries, MRI safety information, storage conditions, and specialized regional coding. Managing thousands of SKUs across five different global databases via manual entry is mathematically impossible to sustain without errors.

PLM/ERP: The Natural Source of Truth

To automate, you first need to identify your “Golden Record.” For most medical device manufacturers, the PLM system is the natural candidate.

The PLM holds the technical DNA of the device. It knows the dimensions, the materials, the sterilization methods, and the packaging hierarchy. It tracks the version history and the exact moment a design change is approved.

However, PLM systems are designed for engineers, not regulators.

• The Language Gap: Your PLM might describe a material as “316 Stainless Steel.” EUDAMED might require a specific coded value like “MT-1234.”
• The Structure Gap: Your PLM views products as a Bill of Materials (BOM). Regulators view products as a UDI-DI linked to a Basic UDI-DI.
• The Validation Gap: PLM systems do not inherently know that if you select “Sterile,” you must also provide a sterilization method code.

This is why direct automation has historically been difficult. You cannot simply “plug” a generic PLM into EUDAMED. You need an intelligent translation layer.

The Integration Architecture: Bridging the Gap

Automating the Last Mile requires a specific architecture. It is not about replacing the PLM but extending its reach. The most effective approach involves a specialized Regulatory Information Management (RIM) or UDI submission platform that sits between the PLM and the regulators.

Here is how the automated workflow operates:

1. Data Ingestion and Mapping

The process starts with an API trigger or a scheduled export from the PLM. The integration layer pulls the raw product data. Crucially, this system maps the engineering data to regulatory fields. It translates internal codes into the standardized languages required by the FDA (GUDID), the EU (EUDAMED), or the NMPA (China).

2. Validation Rules Engine

Before data ever leaves your secure environment, it must be validated. The integration software mimics the validation rules of the target database. It checks for conditional logic errors that a human might miss. For example, it ensures that the sum of the packaging layers matches the hierarchy levels. If an error is found, the system flags it back to the PLM user immediately, preventing a failed submission later.

3. Machine-to-Machine (M2M) Submission

Once validated, the data is transmitted via a Machine-to-Machine (M2M) connection. This is the secure, encrypted highway that connects your systems directly to the FDA’s Electronic Submissions Gateway (ESG) or the European Commission’s access points. There is no logging into a web portal. There is no manual typing. The data flows silently and securely.

4. The Feedback Loop (The ACK)

Automation does not end with sending data. The system waits for the “Acknowledgement” (ACK) from the regulator. This digital receipt confirms the data was accepted and published. The integration software captures this ACK and writes the status back into your internal records, closing the loop.

The Strategic Benefits of Automation

Moving to an automated Last Mile strategy offers benefits that go far beyond just saving time.

Data Integrity and Consistency

When you automate, you ensure that the data in the public domain is an exact mirror of your internal data. There is no risk of a version mismatch where the PLM says “Version 2.0” but the FDA database still says “Version 1.0” because someone forgot to update it.

Scalability for New Markets

Global mandates are expanding. Australia, Brazil, Saudi Arabia, and Singapore all have UDI requirements. If you rely on manual entry, entering a new market requires hiring more staff to type data. With an automated integration layer, entering a new market is often just a matter of configuring a new connector. The core product data remains the same; the system handles the formatting for the new destination.

Rapid Response to Change

Regulatory data models change. EUDAMED updates its validation rules frequently. If you built a custom, hard-coded link, these updates break your system. Using a dedicated compliance software layer insulates your PLM from these external shocks. The software provider updates the rules, and your connection remains stable.

Implementing the Sprint: A 4-Step Guide

If you are ready to move from manual chaos to automated control, here is a roadmap for the integration project.

Step 1: The Data Audit

Before you connect any wires, look at your data. Is your PLM data clean? Do you have the necessary attributes populated? You cannot automate a mess. You may need to run a data remediation project to fill gaps in the PLM, such as missing GMDN codes or incomplete packaging dimensions.

Step 2: Define the Source of Truth

Decide which system owns which field. The PLM likely owns the technical specs. The ERP might own the commercial status. A RIM system might own the regulatory approval dates. distinct ownership ensures that the integration pulls the right data from the right place.

Step 3: Select the Middleware

Choose a UDI compliance solution that offers pre-built connectors. Building a direct connection to the FDA or EUDAMED from scratch is expensive and requires constant maintenance. Buying a solution that specializes in M2M connectivity is almost always more cost-effective than building it in-house.

Step 4: Phased Rollout

Do not try to automate all products for all markets at once. Start with one product family and one market (e.g., FDA GUDID). validate the flow. Once the pipe is working and the data is flowing correctly, expand to other product lines and more complex markets like the EU.

Future-Proofing Your Compliance

The era of “static” compliance is over. Data is now dynamic. Devices receive software updates, labels change, and manufacturing processes evolve. Each of these changes triggers a ripple effect of data requirements.

By automating the Last Mile, you transform compliance from a bottleneck into a background process. You free your high-value Regulatory Affairs talent from the drudgery of data entry, allowing them to focus on strategy and market access.

As we look toward the heavy compliance deadlines of 2026 and 2027, the question is not whether you can afford to automate. The question is whether you can afford not to. The risk of human error in a transparent, digital world is simply too high. It is time to let the machines handle the data so you can handle the innovation.

If you are looking for a robust platform to bridge your internal systems with global regulatory databases, DDi offers the technology and expertise to make the connection seamless.

Explore the Global UDI Compliance Solution by DDi.