COSMO Unique Device Identification
COSMO Unique Device Identification (UDI) is mandatory for medical device manufacturers when the European Medical Device Regulation (MDR) is in force. In many countries, such as the USA, the UDI system is already mandatory. The main objective of UDI is to ensure that medical devices can be clearly identified and traced throughout their entire distribution and use cycles. The UDI requirements stipulate, among other things, that medical devices worldwide must bear a unique product number (Device Identifier), which is printed on the product itself or on its outer packaging by means of a barcode or data matrix. In addition, dynamic product information (Product Identifier), such as the serial/batch number, the expiry date or the date of manufacture must also be applied. COSMO UDI supports you in meeting the requirements of the new labeling regulations.
Since the requirements of the American authorities, such as the U.S. Food and Drug Administration (FDA), differ fundamentally from the requirements of the EU Medical Device Regulation, COSMO UDI offers two separate areas of application. For each application area, the static product/device information or attributes can be recorded, reviewed, and used. The system enables data management at both item and variant level.
The following figure illustrates an overview of the UDI Components.
Key Features
- Integrated UDI product data management according to FDA and EU MDR
- Management of relevant master data and attributes for classification and identification of medical devices (basic DI, DI, direct marking, alternative DI, other additional product attributes)
- PI data directly from the ERP system
- Label printing support for GS1 / HIBC standards
- Printing processes incl. the print data as well as prepared interface for the connection of label printing software, such as NiceLabel
- Simple XML export as a basis for data upload to the GUDID or EUDAMED database
- Intelligent user interface through dynamic display/hiding of necessary data entries including logical data checks
- Complete integration into Microsoft Dynamics 365 Business Central
COSMO Unique Device Identification functionalities are accessed using the Tell Me feature in Microsoft Dynamics 365 Business Central. Choose the 
icon, enter the page name, and then choose the related link.
Document References
| Title / Version | Link | Short description |
|---|---|---|
| Microsoft Docs: Online help for using Microsoft Dynamics Business Central | Welcome to Microsoft Dynamics 365 Business Central - Business Central (Microsoft Docs) | Online Help, Microsoft Dynamics 365 Business Central |
| Validation Toolkit URS RAS100.050_001 Unique Device Identification | User Requirement Specification |
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