The EU medical device regulations (MDR) also establish traceability obligations for manufacturers and other economic operators. Article 27 requires manufacturers to assign a UDI-DI and UDI-PI to each device and submit core data to the EU UDI database as the foundation for traceability across the EU supply chain.
Effective anticounterfeiting controls combine readable marks with secure records, access controls, supplier oversight, and procedures for investigating discrepancies. UDI provides an identification mechanism, while connected records and verification procedures help teams determine whether a product’s history matches authorized activity.
Turning UDI Data into Faster, More Targeted Recalls
When a device defect emerges, manufacturers need to identify affected products, locate inventory, and determine which customers or distributors need notification. Accurate UDI and production records help teams establish the scope of a recall and set corrective action.
Product handling records can add useful context. An analysis of 15,710 drug recalls from 2012 to 2023 identified 833 recalls involving inadequate packaging and storage.
The U.S. Government Accountability Office also examined 3,934 medical device recalls initiated during fiscal years 2020 to 2024. Its report found that 74% exceeded the FDA’s 90-day goal for recall termination, identifying resource limitations and oversight gaps among the challenges companies faced.
Medical device manufacturers must focus on documented product conditions by connecting identification records with relevant packaging and distribution information. Together, this data can help investigators trace problems to specific products and promptly determine the appropriate action.
How UDI Data Elevates Shop Floor Quality Control
For example, an increase in unreadable codes may coincide with a resin change, a laser adjustment, or a particular production shift. Engineers can compare records to identify the likely cause and update processes when necessary.
UDI delivers lasting value when manufacturers connect reliable device identification with production, distribution, and quality systems. Accurate records support targeted recalls, counterfeit investigations and more informed shop floor decisions.
source: MPO
