UDI system of the FDA

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To comply with the legal requirements of the FDA, medical device manufacturers must comply with the UDI (Unique Device Identification) requirements in the future.

All medical devices which fall under the definition of medical devices of the IMDRF (International Medical Device Regulators Forum) formerly GHTF (Global Harmonization Task Force), belong to the scope of UDI. All manufacturers exporting to the USA must have implemented the globally uniform system for the identification of medical devices in their ERP system within the next few years. For the implementation of UDI, medical products were divided into various risk classifications.

 

Timetable for FDA UDI implementation

High-risk medical devices (Class 3)  1 year after entry into force of the law (24.09.2014)
Medium-risk medical devices (Class 2) 3 years after entry into force of the law (24.09.2016)
Low-risk medical devices (Class 1) 5 years after entry into force of the law (24.09.2022)


 

UDI brings a number of benefits to companies such as better product tracking, increased patient safety and greater protection against product piracy. We support the practical implementation of UDI in the areas of:

  • GAP analysis (master data, label system, GTIN management).
  • Identification of UDI attributes
  • Labeling and print management
  • GS1 barcode consulting (GS1 Code 128, GS1 Datamatrix barcode in SAP,..)
  • Transfer of data to GUDID database (web service with HL7 XML)

 

We also offer  consulting support in the areas of :

  • For the registration of an ESG / Webtrader account
  • Registration of WTHS account for the Webtrader
  • FDA test scenarios and the application for a productive account
  • Correct use of the FDA Webtrader

Watch our UDI module video and get inspired:

 

Download here the information sheet on our UDI FDA solution, and have a look at our dedicated pages:

UDI Solution for FDA as SAP Add-On

FDA GUDID Excel Template

 

Do you want help with this? Do you have any questions? We are here for you.

 

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