The European Union’s Medical Devices Regulation (MDR), published in May 2017, marked a significant shift in how medical technologies are tracked, verified, and brought to market within the EU. With sweeping changes affecting manufacturers, importers, distributors, and notified bodies, the regulation’s provisions on Unique Device Identification (UDI) drew particular attention from supply chain and compliance professionals. Even before formal deadlines loomed, forward-thinking diagnostic equipment makers launched pilot projects in 2017 to explore the practicalities of UDI adoption. These early efforts, often grounded in open standards such as those provided by GS1, offered valuable insights into how device lineage could be mapped accurately and how data could flow seamlessly into emerging regulatory platforms like EUDAMED.
The pilots varied in scope but shared a common objective: to stress-test the assignment and use of UDIs at different points in the supply chain. Participating manufacturers began by working closely with their tiered suppliers to identify all components and subassemblies that required a unique identifier under the new regulation. For some, this revealed surprising complexities, particularly when tracing small-scale parts sourced from multiple jurisdictions or legacy suppliers that lacked formal serialization protocols. The task was not merely to affix codes to finished devices, but to build a complete picture of a product’s genealogy, extending down to critical subcomponents where traceability gaps might otherwise compromise compliance or patient safety.
Mapping suppliers to UDI codes required both technical preparation and robust collaboration. Many companies found that their existing enterprise resource planning systems were not fully equipped to handle the new coding structures, prompting interim solutions that combined internal databases with GS1’s open UDI standard. In some cases, suppliers needed hands-on support to generate or apply UDI-compliant labels, particularly if they were smaller operators or based outside the EU where familiarity with MDR requirements was still limited. Through these efforts, pilot participants began to see the contours of what full compliance would entail: a unified data model that linked physical products, digital records, and regulatory submissions in a coherent and auditable manner.
Once initial coding and mapping were in place, manufacturers turned to the task of uploading data into the European database on medical devices (EUDAMED). With EUDAMED still in a developmental phase, the European Commission provided a sandbox environment where companies could test data submission processes and identify pain points without risk of breaching compliance. This testing phase proved critical for refining internal workflows and ensuring that UDI information could be formatted, validated, and transmitted in accordance with regulator expectations. It also helped highlight the importance of data accuracy at the input stage, as even minor discrepancies could generate rejection notices or necessitate time-consuming corrections down the line.
A key output from these pilots was the creation of structured reports detailing the lineage of selected devices. Such reports typically outlined the component hierarchy, the corresponding UDI codes, and the chain of custody from supplier through to assembly and distribution. These documents were designed not only for internal use but also for sharing with regulators, notified bodies, and key customers who increasingly demanded evidence of robust traceability mechanisms. To assist manufacturers, pilot organizers developed templates that captured the essential data elements while allowing room for company-specific annotations or risk assessments. These templates provided a foundation that firms could adapt as the MDR’s implementation phase advanced and as EUDAMED evolved from sandbox to operational status.
The value of these pilots extended beyond the immediate participants. Their findings informed industry associations, standards bodies, and regulators, helping to refine guidance and support tools that would be critical as wider compliance efforts gathered pace. Moreover, the pilots underscored the practical benefits of early action. Companies that invested time and resources into testing UDI processes before they became mandatory positioned themselves to avoid later bottlenecks and to engage more constructively with suppliers who might otherwise struggle to meet regulatory requirements. This proactive stance also sent a clear signal to investors, healthcare providers, and patients that quality and safety were being prioritized well ahead of legal deadlines.
In reflecting on the first year of MDR-driven UDI pilot activity, several lessons emerged. Chief among these was the need for end-to-end visibility across complex supply chains, something that could not be achieved through technical solutions alone. Human relationships—between manufacturers and their suppliers, between industry and regulators—proved just as important in ensuring that traceability systems could function as intended. Additionally, the pilots highlighted the critical role of open standards like GS1’s UDI framework in fostering interoperability and reducing duplication of effort across borders and business units.
The experiences gained in 2017 would continue to shape the medical device industry’s approach to MDR compliance. As the regulation’s staggered deadlines approached and as EUDAMED moved closer to full deployment, companies that had engaged in these early pilots found themselves with a meaningful head start. Their work demonstrated that while the path to UDI compliance was not without challenges, it was navigable with the right mix of preparation, collaboration, and technical rigor.