UDI Packaging Data Challenges: How to organize

UDI is becoming an important part of medical device labeling, traceability, and regulatory data management. For manufacturers selling across multiple markets, one of the more difficult areas is keeping packaging details accurate and consistent from the product level through regulatory submissions.

The challenge becomes more complex when packaging configurations, device identifiers, production information, and market-specific requirements change over time.

Why UDI Packaging Data is a Challenge to Maintain

UDI requirements connect physical product packaging with structured regulatory data. In the U.S., the FDA generally requires device labels and packages to include a UDI, with information submitted to the GUDID/EUDAMED and others. UDI information is provided in both human-readable and machine-readable forms.

Packaging structures can include multiple levels, such as the individual device, immediate package, and higher packaging configurations. Agencies specifically recognize different labeling and packaging levels where a UDI may appear.

For manufacturers, this means packaging information needs to remain aligned with the corresponding UDI data. Changes to package quantity, configuration, labeling, or other product information can create additional data management requirements.

Common UDI Packaging Challenges

1. Managing Multiple Packaging Levels

A medical device may be supplied individually, in a box, or as part of a larger packaging configuration. Maintaining the correct relationship between these levels can become difficult when information is managed across separate spreadsheets, labeling systems, ERP platforms, or PLM systems.

2. Keeping Packaging and Regulatory Data Consistent

Packaging teams and regulatory teams may work with different systems or datasets. If a packaging attribute changes without being reflected in the UDI master data, inconsistencies can arise between the physical label and the regulatory submission.

3. Supporting Different Market Requirements

Global manufacturers may need to prepare UDI data for global submission databases, alongside requirements in other markets. Each regulatory authority can have different data structures, validation rules, and submission formats.

This has become particularly relevant in Europe. The European Commission states that the EUDAMED UDI/Device module became mandatory to use on May 28, 2026. Manufacturers must submit UDI/Device information for devices placed on the EU market.

4. Handling Changes Throughout the Product Lifecycle

UDI packaging data is not a one-time submission task. Product, packaging, labeling, and regulatory information can change throughout the device lifecycle. Teams therefore need a reliable way to identify relevant changes and assess whether updated UDI data or submissions are required.

Options to Improve UDI Packaging Data Management

A useful starting point is to establish a centralized source of UDI master data. This helps teams maintain consistent product and packaging information rather than relying on multiple disconnected spreadsheets.

Pre-submission validation can also identify missing fields, incorrect formats, and inconsistencies before data is submitted. This is especially useful when the same product information needs to be prepared for different regulatory databases.

Integration with existing enterprise systems can further reduce duplicate data entry. Where appropriate, connections with ERP, PLM, RIM, or labeling systems can help maintain a more consistent flow of product and packaging information.

The objective is not simply to generate a UDI submission file. It is to maintain accurate UDI data throughout the product lifecycle and keep packaging information aligned with regulatory records.

For organizations looking to manage UDI data across markets, Visu UDI – Global UDI Compliance Solution by DDi provides capabilities for centralized UDI master data management, validation, and preparation of submissions for regulatory databases including FDA GUDID, EUDAMED, Swissmed and others.