Home » EC Creates Helpdesk for Devicemakers on UDI Requirements
EC Creates Helpdesk for Devicemakers on UDI Requirements
Devices Regulatory Affairs
The European Commission has launched an online helpdesk for devicemakers that must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26.
Before a device can be placed on the EU market, devicemakers must submit the UDI number along with other details to the Eudamed database, which will be used to monitor the safety and performance of devices under the MDR.
UDI labeling enables the identification and tracking of medical devices throughout the supply chain, so it will be used for postmarket safety activities, adverse event reporting and field safety notices.