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.
Continue Reading Commission Recommendation on Unique Device Identification System in the EU