SAP Consulting and Software Validation

Unique Device Identification

Unique Device Identification (UDI)

Clear labeling of medical devices for increased security and transparency in the supply chain

Unique Device Identification (UDI) is a directive of the FDA, the US federal agency to monitor food and drug administration, for the implementation of clear labeling for medical devices. This policy aims to increase transparency in the supply chain, improve patient safety and simplify product recalls.

The FDA introduced the UDI uniform labeling system for medical devices on September 24, 2013. For all medical device manufacturers who want to continue to export their products to the US market, this means that all products that fall under the definition of medical devices of IMDRF (International Medical Device Regulators Forum), must have introduced the UDI system before the deadline. In addition to the current UDI requirements in the US (and Turkey), more binding rules for the EU and Asia are in the making. In Europe, a “system of unique product numbers” will be introduced, bringing into effect the new European legislation for medical devices.

The FDA’s UDI System

HIBC AnwendertagSince 2013, the “FDA final rule” has required manufacturers of medical and In-Vitro Diagnostic Products (IVD) to provide their products with a globally unique identification number with defined manufacturing and production information. These markings must be applied in plain text as well as in a machine readable form, at all relevant levels of packaging a product, e.g. in the form of barcodes or 2D codes.

Uniqueness is achieved in that the batch/lot no., serial number or the expiration date of the product are a part of the UDI. In addition, the manufacturer must define product-specific master data records in a central government database (GUDID). You can access this information using the unique identification number. Since September 2014, the rules already apply to most strictly controlled Class III medical devices (e.g. implants, HIV tests, …). These rules will be extended to other classes of medical devices by 2018.

DHC supports you with the

  • Definition of the specific UDI requirements
  • Identification of the necessary data
  • Creation of the data model for labels and for transmission to the GUDID
  • Implementation in SAP
  • Definition and implementation of the labeling requirements (e.g. new barcodes)
  • Validation of implementation
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