Unique device identification system
Information
Type
Miscellaneous
Regulated products
IVDMD, Medical Devices
Topics
Medical Device Industry
Last updated
February 12, 2024
Description
The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basic UDI-DI, which identifies a group of devices and is the main key information in the Eudamed database as well as relevant documentation such as certificates and declaration of conformity; producing a UDI (unique device identifier) consisting of a UDI device identifier ("UDI-DI") and a UDI production identifier ("UDI-PI"); affixing the UDI vector on the device label and all external packaging layers; and recording and storing the UDI. The UDI applies to all devices other than custom-made devices and devices under clinical investigation or a performance study. The UDI is a unique numeric or alphanumeric code associated with a medical device, which allows for clear and unambiguous identification of specific devices placed on the market. The numeric or alphanumeric character set is provided by the so-called issuing bodies designated by the European Commission (for more details see Commission Implementing Decision 2019/939 ). Before a device can be placed on the market, each manufacturer must: assign a basic UDI-DI and a UDI (UDI-DI and UDI-PI); affix the UDI vectors on the device label and on all external packaging layers transmit in Eudamed the information about the device in question. See the UDI helpdesk
Tags
Organization
Country / Region
Italy
License
Creative Commons Attribution 3.0