Jens Fröhlich
Principal Consultant Operations – Portfolio Management MEDTEC
The requirements surrounding UDI (Unique Device Identification) marking have actually been clearly regulated for years. Medical devices must be uniquely identifiable and traceable. Within the EU, device registration takes place via EUDAMED, and in the US via GUDID.
Complexity behind the labeling
The UDI code is not just a technical marking, but an expression of a structured data model. Many UDI pieces of information, such as the article, serial or batch number, manufacturing date, or expiration date, must be consistently documented throughout a product's entire life cycle. Even minor changes to master data—or to the packaging unit or materials, for example—can require re-registration.
This is where process disruptions often occur, especially in medium-sized companies. Changes to article master data are made manually, roles and responsibilities are not clearly defined, and automated review routines are lacking. If the internal data does not match the published information in EUDAMED or GUDID, this can jeopardize approval in an emergency.
Relevance for traceability and product safety
The requirements for structured data management are further increased by regulatory developments in the area of market surveillance. In the event of recalls or field reports, it must be possible to precisely trace which serial number or UDI was delivered, when, and where. Such analysis is virtually impossible without digital traceability.
The requirements for data quality, versioning and consistency are also increasing accordingly.
Requirements for ERP systems
Modern ERP solutions generally provide the technical foundation for maintaining UDI-relevant information in a structured manner. However, the key factor is how these functions are embedded organizationally. These include:
- Central data source for manufacturer and article information
- Consistent maintenance processes for fields according to EUDAMED and GUDID requirements
- Clear allocation of roles with defined approval processes
- Integration of label software that automatically transfers all relevant data
- Complete traceability down to batch or serial number level
A software solution alone is not enough – without clear processes and responsibilities, UDI compliance remains vulnerable to errors.
ERP industry software KUMAVISION medtec365 for medical technology Manage all UDI-relevant data directly in the system. This simplifies master data maintenance, data monitoring, and tracking in the event of complaints. A dedicated authorization concept ensures that data can only be edited and changed by authorized persons. Digital approval processes support tracking and traceability.
UDI is not a purely technical issue. The structural and organizational integration of UDI requirements into company processes is crucial. Reliable data management, consistent traceability, and clearly defined roles are essential for legally compliant implementation.
Another advantage: Companies that think beyond the barcode and understand their master data as a central control instrument can not only meet regulatory requirements but also make their internal processes more efficient – and react more quickly and specifically in an emergency.
Further information
If you are interested or have any questions, please contact Philip Wilde.
Email: This email address is being protected from spam bots! To display JavaScript must be turned on.
LinkedIn: LinkedIn Philip Wilde
