LANSA Data Sync Direct

GDSN and Product Information Management Solutions for GS1 Compliance

UDI is a global normalized system for the identification of medical devices. The UDI should be visible, machine-readable and in plain text on the product itself. The UDI system also includes the development and operation of a UDI database (UDID) that contains a variety of information about the products.

Advantages of the UDI system

UDI consists of 3 elements

UDI System
  1. Product data (consisting of DI and PI)
    • Device Identifier (DI): Fixed, ISO-based code for item identification
    • Production Identifier (PI): variable data, e.g. lot number, serial number, expiry date
    • DI must be globally unique and based on ISO standards
    • The manufacturer establishes the UDI (DI + PI) according to the rules of international coding standards e.g. GS1 Global Trade Identification Number (GTIN)
    • The UDI is assigned to the product or its packaging
    • Every packaging stage needs a separate UDI
  2. Data carrier
    • Linear barcode or 2D code
    • Based on ISO standards
    • The data carrier contains DI and PI, machine readable and in plain text
    • The manufacturer establishes the data carrier according to the rules of the international coding standards (e.g. GS1-128, Data Matrix)
    • UDI be applied on the label, the packaging or the medical device and on all other packaging hierarchies
    • Reusable devices require a permanent UDI identification mark
  3. Database (UDID)
    • Database contents: product information (e.g. registered trade name, dimensions, storage conditions) and packaging hierarchy (The GHTF provides up to 22 core elements)
    • Data should be public and free of charge
    • The manufacturer is responsible for data entry, i.e. information of new UDI's have to be received in advance of the market launch and updating of product data has to be handled within 30 days
    • HL7 standards are used for the data synchronization.
    • Regional or national UDID's can contain additional data elements
    • The UDID should allow a combination of all packaging hierarchies of the particular medical device

UDI coverage

All medical devices, which belong to the definition of medical devices on the strength of IMDRF (International Medical Device Regulators Forum) formerly GHTF (Global Harmonization Task Force), are part of the coverage of UDI. The UDI guidelines provide a framework for regulatory authorities. See www.imdrf.org/documents/documents.asp for more information.

Timetable for the introduction of UDI

In Europe, the UDI system from the new Medical Device Directive (MDD) will be anchored and expected to take effect in 2013.

The possible legal validity of UDI on the national level will depend on the risk category of the medical devices: