Introduction to the basic concepts of medical device Unique Identification (UDI)

Unique Device Identification (UDI), also known as the unique identification of medical devices, is a string of codes consisting of symbols, numbers, or letters, usually attached to medical device products and packages. As the most important link in the unique identification system of medical devices, it is globally unique and can be used for accurate identification of medical devices, facilitating supervision and traceability, so it is also known as the "digital ID card" of medical devices.

UDI exists in the whole life cycle of medical device production, circulation and use, and is the basis of accurate identification of medical device information. Its implementation will reduce the barriers to inadequate recognition of medical devices in the market, quickly and accurately identify critical information for device safety and effectiveness, and reduce the resulting medical errors.

At the same time, UDI systems can improve the quality of medical device adverse event reporting, more effectively identify product problems, and more quickly recall faulty devices to ensure patient safety.

According to relevant coding rules, UDI consists of product identification (DI) and production identification (PI) :

Unique Device Identification (UDI), also known as the unique identification of medical devices, is a string of codes consisting of symbols, numbers, or letters, usually attached to medical device products and packages. As the most important link in the unique identification system of medical devices, it has global uniqueness and can be used for accurate identification of medical devices and facilitate supervision and traceability.

It exists in the whole life cycle of the production, circulation and use of medical device products, and is the basis of accurate identification of medical device information. Its implementation will reduce the barriers to inadequate recognition of medical devices in the market, quickly and accurately identify critical information for device safety and effectiveness, and reduce the resulting medical errors.

At the same time, UDI systems can improve the quality of medical device adverse event reporting, more effectively identify product problems, and more quickly recall faulty devices to ensure patient safety.

According to relevant coding rules, UDI consists of product identification (DI) and production identification (PI) :

DI is static product information, including enterprise code and product ID. Among them, the enterprise code is the unique code applied by the recorder and issued by the code issuing institution in line with the coding rules and standards of our medical devices. A product ID is a code containing the name of a specific product, package grade, specification and model. Therefore, DI, which is a combination of enterprise code and product ID, is globally unique.

PI is product dynamic information, including production date, expiration date, production batch, serial number, check location, etc. At present, PI code does not need to be uploaded to the database of the Food and Drug Administration for the time being, and each user can directly obtain product-related production information by using scanning equipment.