During our recent webinar on UDI (UDI for medical devices – practical examples and lessons learned), we saw a high level of engagement. It quickly became clear that many companies are in the midst of a transformation where regulatory requirements, labelling, and data sharing are no longer side issues, but have become central elements in how medical devices are developed, marketed, and used going forward.
Below is a summary of some of the most common questions raised during the webinar, with answers that provide an overview to help manufacturers, distributors, and healthcare providers navigate the landscape.
1. In what order should GS1 identifiers appear?
Many wonder whether Application Identifiers (AIs) must follow a specific sequence, such as 01 always followed by 17. The answer is that the structure must comply with the GS1 standard, but the order can be adapted based on the product, label space, and process. The key is that all mandatory AIs are included and that the code is machine-readable.
2. Who determines the risk classes, and how do you know which class applies?
Risk classes are defined according to MDR/IVDR, and the manufacturer is responsible for the classification. The assessment is based on the intended use and risk profile of the product. The classification rules in the legislation are therefore always the starting point when determining a product’s class.
3. What are the quality requirements for a UDI DataMatrix code?
A common question is whether the code must be readable by mobile apps. UDI markings must be readable by approved scanners within the healthcare supply chain, and the quality must meet relevant verification standards (e.g., ISO/IEC 15415 for 2D codes). While readability via a mobile app is a good indicator, it is not proof that the marking meets the requirements in the healthcare environment.
4. How should products without an expiry date be handled?
Products such as eyeglass frames often do not have a natural expiry date. In these cases, no expiry date is required, provided this aligns with the regulations and the product does not include other elements such as batch/lot numbers or expiry dates that differentiate units of the same model.
5. What is the difference between UDI-DI and UDI-PI?
This is a frequent source of confusion. UDI-DI is the static part of the UDI structure and identifies the product model or type. UDI-PI contains variable information, such as batch numbers and expiry dates.
6. Can hospitals and regions use EUDAMED as their master data source?
Many hope that EUDAMED will serve as a central source. In practice, however, regions often need to supplement it with additional data and local processes. UDI information is an important component, but EUDAMED does not constitute a complete master data solution.
7. Is it possible to register the same product information in both GUDID and EUDAMED through one system?
Interest in a “single source of truth” is high. Today, systems exist that support both EU and US requirements, but the information must still be submitted to each regulatory database separately. Automation can, however, significantly reduce duplicate work.
8. Who is responsible for the UDI-DI – the manufacturer or the importer?
The general rule is that the manufacturer is responsible for the UDI structure. Importers and distributors may have their own GS1 company prefix, but this does not change responsibility for the product’s UDI-DI.
9. What applies when a product is sold under the distributor’s own brand?
When a distributor places its own brand on a product, they are considered the “legal manufacturer.” Their UDI-DI and associated regulatory information must then appear on the packaging.
10. When is it considered “not technically possible” to mark a product?
If a product is so small or sensitive that marking it would compromise its function or safety, exemptions may apply. The assessment must be documented and justified, and alternative marking methods should be considered.
A strong will to do things right
The webinar highlighted something positive: the will to comply and improve is strong. Companies want to work more data-driven, more consistently, and more future-proof. At the same time, the challenges are significant, and the need for support, standards, and shared understanding is clear. Ultimately, it is about creating trust throughout the value chain — from manufacturers to healthcare providers, and ultimately to patients.
Author: Olivia Karringer, Client Manager, GS1 Sweden
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