UDI system of the FDA
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 global UDI solution video
Our SAP Add-On solution is not only quick and easy to install but also flexible in terms of required UDI authority support and pricing.
Supported by S/4 HANA, SAP Netweaver 7.50 and higher, as well as the Private S/4 Hana Cloud, our solution offers a frontend base on SAP Fiori and SAP Ui5 technology, accessible via web browser.
The Key Benefits of a UDI Software Solution
Experience the benefits of our global UDI solution. As a manufacturer of medical devices, you face the challenge of ensuring the safety and effectiveness of your products while meeting the requirements of regulatory authorities worldwide.
A Global Unique Device Identification solution can help you overcome these challenges while optimizing your business processes.
Download here the information sheet on our UDI FDA solution, and have a look at our dedicated pages:
Do you want help with this? Do you have any questions? We are here for you.