On 5 April, 2013 the European Commission adopted a recommendation on a common framework for a unique device identification (UDI) system in the EU. The hope is that a harmonized UDI system will facilitate device safety monitoring and reporting, recalls, and other field safety corrective actions. It will also help avoid device-related medical errors and injuries and support anti-counterfeiting efforts.
The Recommendation seeks to harmonize UDI mechanisms established at national and/or regional level that allow tracing of medical devices. This will help ensure compatibility of these systems with the proposed EU UDI system, the implementation date of which is not yet clear.
Traceability of medical devices is currently not regulated in the EU, but the proposed EU Medical Devices Regulation includes specific traceability provisions and envisages a mandatory internationally compatible UDI system for the EU. Pending the establishment of this EU level UDI system, the Recommendation sets out the data elements that Member States must include in national UDI databases and proposes conditions for economic operators, health professionals, and professional users.
The Recommendation applies to medical devices, active implantable devices (other than devices which are custom-made or intended for clinical investigations) and in vitro diagnostic medical devices (other than those manufactured in health institutions and for performance evaluation), including their accessories. It recommends that Member States follow a risk-based approach to the implementation of national UDI systems, with a gradual implementation of a system, starting with higher-risk class III devices.
The UDI itself comprises two parts, a device identifier and a production identifier. The device identifier should contain information specific to the manufacturer and the device model. It is linked to information uploaded to national databases and, once established, the European UDI electronic system, which will form part of the future centralized European databank on medical devices (Eudamed).
The production identifier is equivalent to a batch or product number, which would allow traceability of defective products or product batches.
Manufacturers should attempt to apply UDIs in both human readable (alphanumeric) and Automatic Identification and Data Capture (AIDC) formats. Where possible, they should appear on the device label, its package, or on the device itself (e.g., as a direct part mark), and on all other packaging levels.
The Recommendation is consistent with the approach developed at international level, which should help minimize implementation costs for manufacturers and facilitate traceability and free movement of goods internationally. However, it is not only manufacturers that should keep a close watch on the development and implementation of national UDI systems and the UDI system of the EU. The Recommendation proposes obligations to be fulfilled by other individuals, including importers, EU authorized representatives and distributors, for example, verification and electronic record keeping of a device’s UDI information.