UDI (Unique Device Identification) is a code consisting of numbers, letters, or symbols that is attached to a medical device product or package to uniquely identify the medical device.
The complete UDI system consists of three parts: the unique device identification, the data carrier and the database. The unique ID is the electronic ID of the medical device product; the data carrier is the data medium for storing or transmitting the unique ID of the medical device; the database is the database for storing the product ID and related information of the unique ID of the medical device.
In the context of the information age, UDI is the key basic element to realize the automated identification of medical device products, accurate recall, tracking and tracing, the whole process of general checking and identification, information interconnection and intelligent management.
Composition of UDI:
UDI consists of Device Identification (DI) and/or Production Identification (PI).
DI is a mandatory, fixed part of the UDI and consists of two parts: the corporate identification code and the product specification code. The enterprise identification code is applied by the registrant or the filer, and accepted by the code-issuing organization in accordance with China's medical device coding rules and coding standards on the basis of the application, and assigned the globally unique enterprise identification code; the product specification code is the code prepared by the registrant or the filer based on the characteristics of the product model, specification and packaging produced by the registrant or the filer. The DI consisting of the enterprise identification code and the product specification code is globally unique.
PI is a non-required, variable part of the unique identification of a medical device, including the date of manufacture, expiration date, batch number or serial number, etc. The data of PI does not need to be uploaded to the coding database, and all the units can use common scanning equipment to parse the relevant production information locally.
UDI should comply with the principles of uniqueness, stability and scalability. Uniqueness is the first principle of UDI, to ensure that the unique identification of the product is not duplicated is the basis for accurate identification, but also the core principle of the unique identification function; stability principle requires that the UDI should be related to the basic characteristics of the product, if the basic characteristics of the product has not changed, the product identification should remain unchanged; scalability principle requires that the UDI should be adapted to meet the requirements of the regulatory requirements and practical application of the continuous development.