Core objectives of the UDI system
Patient safety:
The overall goal is to increase patient safety by preventing device misidentification and mix-ups and by resolving medical device issues more quickly. For this purpose, all medical devices are recorded centrally in the EUDAMED - European database for medical devices. Link to research in the EUDAMED database: https://ec.europa.eu/tools/eudamed/#/screen/search-eo
Traceability:
Complete and transparent traceability of products from production to use enables affected devices to be quickly located.
Efficient product recalls:
In the event of a recall, manufacturers, healthcare providers and regulators can quickly and accurately identify and locate affected products.
Fighting counterfeits:
Clear labeling makes it easier to identify counterfeit or illegally sold medical products and remove them from the market.
Improved data basis:
The system provides a broader database that helps manufacturers analyze application errors and continuously improve the quality of their products.
Optimization of supply chains:
Unique identification supports better inventory management and device tracking throughout the supply chain.
Enabling post-market surveillance:
UDIs serve as the basis for collecting and analyzing performance and safety data, enabling more effective monitoring.
