UDI Compliance and the Future of Medical Device Data

The Day of Reckoning is Nigh | The Role of UDI and the Future of Data in the Medical Device Ecosystem

As the European Database on Medical Devices (EUDAMED) deadline approaches (for real this time), I watch many – and help some – companies continue to repeat their Unique Device Identification (UDI) sins of the past.

When we first started on our UDI journey circa 2013, many companies were shocked to realize they didn’t actually have the data needed in any system, or stored in a computable way, to meet the U.S. FDA’s GUDID requirements. So started the GUDID spreadsheet sprint — lots of people running around, looking at actual labels, packages, and paper files, trying to figure out the required data and then sticking it into a spreadsheet. Sometimes, the spreadsheet was uploaded by a third party, or simply manually cut and pasted into GUDID.

Those medical device manufacturers lucky enough to have some of the data in a system (e.g., a PLM) were able to temporarily augment that data and submit it “automatically” (machine-to-machine). Some of these system vendors supported this submission process, others developed their own HL7 SPL submission capabilities, and still others leveraged a host of third-party vendors.

Then, as we rolled into 2016, with GUDID submissions moving along and the EU’s EUDAMED staring us in the face — not to mention other regulators starting their UDI journeys — many companies realized they couldn’t sustain the current approach. They needed a more holistic and systemic way of creating and managing UDI data.

Some looked to expand the data models in the systems they used for GUDID. Others purchased new systems under the guise, to some extent, of solving the UDI data challenge. But then EUDAMED was delayed, and attention (and budget) shifted to other priorities. Many of the vendors that had supported GUDID data collection and submissions exited the business — primarily, I think, because solving this problem is really hard.

And so today, here we are: in the midst of the EUDAMED spreadsheet sprint. Or, maybe worse, pretending that we are making progress by storing the data in a destination-specific (e.g., EUDAMED) folder of a system.  Much like a pdf of an IFU (an “eIFU”) is really no more useful than the paper IFU itself – creating destination-specific data in a system simply compounds the limitations of linear data collection (and maintenance).

The challenge of UDI — along with other global, data-centric regulatory and commercial requirements — lies not just in managing data for initial submissions, but in maintaining that data consistently over time.

It’s not enough to ensure consistency across global UDI database submissions. That same data must also align with other regulatory and commercial submissions. Many have already experienced this firsthand — for example, receiving a letter from the U.S. FDA asking why the information in an adverse event report, recall notice, or R&L doesn’t match what was submitted to the GUDID. Increasingly, other regulators are — or soon will be — doing the same.

Emerging import control requirements will create new complexity.  If the data used during importation doesn’t match previously submitted UDI data, the device will likely be blocked from entering the market. This risk extends beyond regulatory issues: mismatches or inconsistencies can disrupt purchasing and fulfillment processes, delay (or cease) reimbursement, hinder traceability, and complicate recalls and participation in registries.

And we haven’t even touched on the implications for Real-World Data (RWD) or Post-Market Clinical Follow-up (PMCF). As an industry, we’ve focused heavily on getting new (or new versions of) devices to market — and have traditionally minimized the ongoing need to demonstrate that a device remains safe, effective, delivers on its intended use, and justifies its cost throughout its lifecycle.  The new EU MDR and IVDR requires this ongoing justification.

Solving this challenge requires the coordinated implementation of three interrelated activities:

1. Developing and implementing a holistic UDI (and related) data superset that covers all regulatory and commercial needs globally,
2. Extracting individual data attributes from a Single Source of Truth (SSOT) to ensure consistency across systems and submissions, and
3. Establishing a highly robust, cross-organization data governance and change management process to maintain data integrity over time and across functions.

We are very good at creating new UDI data for the same device across different geographies – and different answers to a data question through (increasingly robust) siloed processes and systems (e.g., labeling, RIMS, PLM, ERP, CAPA, AE reporting, recalls).  We need all three, in concert, to be successful in the long term.

Structured data, centralized governance and control, and automation can provide both greater visibility and consistency.  Collaboration between all affected parts of the organization (e.g., engineering, regulatory, quality, labeling, marketing, supply chain) will provide not only consistent data but also a robust change control process that propagates reliably correct data to all users.

At USDM, we help medical device manufacturers navigate the complexity of UDI compliance by building sustainable, scalable solutions that go beyond “spreadsheet sprints.” Our experts partner with your teams to design and implement a holistic data model, create a Single Source of Truth, and establish robust governance and automation — ensuring your UDI data is accurate, consistent, and ready for any regulatory or commercial requirement worldwide.

UDI has always been foundational. Linking a well-implemented UDI program to comprehensive, high-quality product data unlocks a wide range of possibilities — from regulatory compliance and market access to supply chain efficiency, patient safety, and real-world evidence.

The question is: Will you be ready for the next data challenge?

 If not, we can help! Contact USDM today.