When the European Union adopted the Medical Devices Regulation (MDR) in May 2017, it set in motion one of the most significant overhauls of medical device oversight in decades. By 2018, attention had turned from the text of the regulation to its implementation. That year saw the emergence of early pilot projects across Europe, as hospitals, clinics, and manufacturers began grappling with the practical challenges of embedding Unique Device Identifiers (UDIs) into their supply chains. These pilots were not merely compliance exercises. They represented critical steps in building the data infrastructure that would underpin future medical device safety, traceability, and accountability across the region.
A key feature of these pilot initiatives was the use of GS1’s open-label standards. GS1, already well established in global logistics and retail, offered an interoperable framework for assigning, capturing, and sharing UDI information. For hospitals and clinics, adopting these standards provided a way to future-proof their procurement and inventory management systems against the demands of MDR. In practice, this meant embedding scannable codes onto medical device packaging, components, and in some cases, even individual parts, such as subcomponent polymers used in devices like catheters and implants. The pilots aimed to test the feasibility of tracking these items across supply tiers, with a particular focus on Tier 2 suppliers that provided critical but often overlooked materials.
One of the most valuable resources for these early adopters was the European Database on Medical Devices (EUDAMED). Though still under development in 2018, EUDAMED offered a sandbox environment that allowed stakeholders to simulate data submissions and verify device entries. Hospitals and clinics participating in the pilots made extensive use of this environment. They tested how device records, once linked to UDIs, could be cross-referenced within the system, allowing procurement teams to verify regulatory status before purchase. This functionality promised to reduce the risk of non-compliant devices entering the supply chain, while also enhancing patient safety by ensuring traceability in the event of a product recall or adverse incident.
For those looking to initiate a small-scale UDI pilot in 2018, the first step was to map the supply chain. This meant identifying not just direct device suppliers, but also the manufacturers of key subcomponents, particularly polymers and other materials integral to device integrity. This mapping process typically involved close collaboration between procurement, compliance, and quality assurance teams, as well as external suppliers. Once a pilot scope was defined, participating organizations worked with their Tier 2 suppliers to assign provisional UDIs to these subcomponents, using GS1 standards to generate codes compatible with EUDAMED’s requirements.
The next phase involved integrating these provisional UDIs into hospital and clinic inventory systems. This step required configuring software to recognize and store UDI data, linking it to purchase orders, inventory counts, and usage logs. Many pilot sites opted to begin with a narrow device category—such as orthopedic implants or vascular catheters—to limit complexity while refining their processes. By focusing on a single category, they could observe how UDI data flowed through their systems, from supplier delivery to patient use, and identify any gaps that needed addressing.
A critical element of these pilots was testing data submission to the EUDAMED sandbox. Here, hospitals and clinics entered UDI information, verified its accuracy, and explored how the system flagged discrepancies or incomplete entries. This stage provided valuable lessons about data quality and highlighted the importance of supplier engagement. In several cases, pilot participants discovered inconsistencies between the data provided by suppliers and the required data fields in EUDAMED, prompting suppliers to adjust their internal record-keeping practices.
Training and capacity building formed an essential part of the pilot process. Staff involved in procurement, inventory management, and clinical use needed to understand not only how to handle UDI-labeled devices, but also the broader regulatory context driving these changes. Pilot sites that invested in comprehensive training found smoother adoption and greater buy-in across departments. This, in turn, facilitated better feedback loops, enabling teams to refine their workflows as they transitioned from pilot to broader implementation.
By late 2018, these early pilot programs had begun to yield insights that would inform wider MDR readiness efforts. They highlighted the technical feasibility of using GS1 open-label standards to track complex supply chains, but also pointed to areas requiring further work. Chief among these was the need for more consistent engagement with Tier 2 and Tier 3 suppliers, many of whom were only beginning to understand how MDR requirements would impact their operations. Additionally, the pilots underscored the importance of ongoing collaboration between regulators, manufacturers, and healthcare providers in refining EUDAMED’s functionality and ensuring that its eventual rollout would meet the sector’s needs.
These efforts, while preliminary, marked a vital step in Europe’s transition to a more transparent and resilient medical device supply chain. They provided a practical roadmap for other organizations preparing to embark on their own UDI pilots and set the stage for broader compliance as MDR deadlines approached. For policymakers and industry leaders alike, the pilots demonstrated that building effective traceability was as much about fostering shared responsibility and alignment as it was about technology.