UDI Labeling in Multilingual IFUs
UDI Codes, EUDAMED, and Device Identification Across Language Boundaries
What Is UDI and Why Does It Affect Your IFU Translations?
The Unique Device Identification (UDI) is a globally standardized system for the unambiguous identification of medical devices. EU MDR 2017/745 mandates that every medical device placed on the EU market must carry a UDI code. This code consists of two components: the UDI-DI (Device Identifier), which identifies the product and its manufacturer, and the UDI-PI (Production Identifier), which contains production-relevant data such as lot number, serial number, expiration date, and manufacturing date.
At first glance, UDI labeling appears to have little to do with IFU translation — after all, the UDI code itself is language-independent. However, upon closer examination, UDI has considerable implications for the design of multilingual instructions for use and labels.
UDI Requirements in the Instructions for Use
According to MDR Annex I, Section 23.2(e), the instructions for use must contain the UDI code of the product. In practice, this means the UDI must be correctly presented in every language version of the IFU. Since the UDI code itself is language-independent, it is reproduced identically across all language versions.
The challenge lies in the accompanying texts: the explanation of what the UDI code is, how it is read, and where it can be found on the product or packaging must be provided in the respective national language. The reference to the possibility of retrieving product information via the UDI in EUDAMED should also be translated.
Consistency Across Language Versions
A critical aspect is consistency: the UDI-DI must be exactly identical in every language version of the IFU. Even a single transposed digit can result in the product being unidentifiable via the UDI database in a particular language version. Implement a verification step in your review workflow that verifies UDI correctness in every language version.
EUDAMED and Multilingual Documentation
EUDAMED (European Database on Medical Devices) is the central European database for medical devices. Manufacturers must register their products in EUDAMED and provide extensive data, including information about the available languages of the instructions for use.
Registration in EUDAMED requires specifying all languages in which the IFU is available. This specification must match reality — if you indicate in EUDAMED that the IFU is available in 20 languages, those 20 language versions must actually exist and be up to date. Discrepancies between the languages registered in EUDAMED and the actually available translations are a common finding during audits by Notified Bodies.
Product Data in EUDAMED
An often overlooked aspect: EUDAMED itself requires the entry of certain product data in multiple languages. The Basic UDI-DI dataset contains fields such as the product description and risk class, which must partially be provided in multiple languages. Ensure that the product description in EUDAMED is consistent with the description in the respective language version of the IFU.
UDI on Multilingual Labels
When designing multilingual labels, UDI labeling presents a particular challenge — but it also offers a simplification. Since the UDI barcode is language-independent, it only needs to be applied once on a multilingual label. This saves valuable space that can be used for multilingual text information.
The Human Readable Interpretation (HRI) of the UDI is also language-independent and is printed only once. However, note that the technical requirements for barcode quality must be met regardless of the language version. The barcode must be created according to the specifications of the respective Issuing Entity (GS1, HIBCC, or ICCBBA), and print quality must be regularly verified.
Space Management on Labels
Multilingual labels face the challenge of accommodating all required information in limited space. UDI labeling occupies a fixed amount of space that cannot be reduced. Therefore, plan the label layout starting from the UDI marking and distribute the remaining space among the linguistic content. For products with very small labels, the use of a booklet label or fold-out may be necessary to accommodate all information in all languages.
Regulatory Requirements Outside the EU
UDI requirements are not limited to the EU. The FDA in the United States has established its own UDI system, as have other regulatory authorities worldwide. If your product is marketed in multiple regions, you may need to address different UDI requirements in different language versions of the IFU.
The International Medical Device Regulators Forum (IMDRF) is working toward global harmonization of UDI requirements. Until this harmonization is fully implemented, manufacturers must be aware of regional differences and account for them in their multilingual documents. manualworks supports you in managing region-specific UDI requirements and correctly implementing them in the respective language versions.
Conclusion
UDI labeling in multilingual IFUs requires precision and systematic approach. While the UDI code itself is language-independent, the requirements for consistency, EUDAMED registration, and label design have direct implications for your IFU translation process. Integrate UDI verification steps into your review workflow and ensure that all language versions contain the identical, correct UDI code.