EU IVDR 2017/746

Language and Translation Requirements for In Vitro Diagnostics

Overview of EU IVDR 2017/746 and Its Language Requirements

Regulation (EU) 2017/746 on in vitro diagnostic medical devices – the IVDR – has been fully applicable since 26 May 2022, replacing the former Directive 98/79/EC (IVDD). For manufacturers of in vitro diagnostics, the IVDR brings fundamental changes, including with regard to language and translation requirements.

Structure of the Language Requirements

The IVDR follows the same basic principle as the MDR in its language requirements: all information to be supplied with the device pursuant to Annex I Chapter III must be provided in the official language of the respective target country. The manufacturer bears primary responsibility, but importers and distributors must also verify compliance with the language obligations.

Specificities of IVD Documentation

Compared to other medical devices, IVD Instructions for Use have certain characteristics that are relevant for translation:

- **Performance data**: Information on diagnostic sensitivity and specificity, analytical sensitivity, measuring range, linearity, and repeatability must be translated with precision and correct technical terminology. - **Specimen handling**: Instructions for specimen collection, storage, and preparation require absolute precision in translation, as errors can lead to incorrect test results. - **Calibration and quality control**: Information on calibration procedures and internal quality controls must use standard laboratory terminology in the target language. - **Interpretation of results**: The description of result interpretation, particularly for qualitative tests, must be linguistically unambiguous.

Devices for Self-Testing – Stricter Requirements

The translation requirements for IVD devices for self-testing (e.g. pregnancy tests, blood glucose meters, self-tests for infectious diseases) are particularly demanding. The IVDR explicitly requires that the Instructions for Use are worded in a way that is comprehensible to lay users. This confronts translators with the task of conveying complex diagnostic concepts in generally understandable language without sacrificing technical accuracy.

Classification and Translation Effort

The IVDR introduces a new risk-based classification system (Classes A to D). Products in higher classes (C and D) are subject to more intensive assessment by Notified Bodies. In practice, this means that the linguistic aspects of the documentation are also scrutinised more closely. Manufacturers of high-risk IVDs should therefore pay particular attention to the quality and consistency of their translations.

Transitional Provisions and Time Pressure

The IVDR provides transitional provisions in Article 110, which were extended by Regulation (EU) 2022/112. Nevertheless, many IVD manufacturers face considerable time pressure to adapt their documentation to the new requirements. The new classification system has resulted in numerous products that previously did not require Notified Body involvement now being subject to conformity assessment by a Notified Body. This assessment also includes a review of the linguistic compliance of the Instructions for Use.

Terminological Challenges in Laboratory Diagnostics

A particular aspect of IVD translation concerns laboratory terminology. Terms such as "sensitivity", "specificity", or "positive predictive value" have firmly defined equivalents in different languages that must be used precisely. Furthermore, clinical chemistry designations for analytes can vary from country to country. Systematic terminology management is therefore especially important for IVD manufacturers.

Translation Management for IVD Manufacturers

The translation needs for IVD Instructions for Use are often considerable: many manufacturers distribute product families with dozens of reagents, each requiring their own Instructions for Use in numerous languages. An efficient translation management system is therefore essential. ManualWorks offers IVD manufacturers a platform specifically tailored to the needs of the diagnostics industry – with terminology databases, translation memory, and full traceability. Through centralised management of all language versions, ManualWorks ensures that when changes are made to a reagent, all associated Instructions for Use are updated promptly and consistently.

Summary

The IVDR 2017/746 sets clear and binding language requirements for IVD manufacturers. The correct translation of Instructions for Use requires specialised expertise and systematic translation management. Particularly for devices intended for self-testing, there are heightened comprehensibility requirements that directly affect the translation process. Early establishment of robust translation processes is not only a regulatory necessity but also a competitive advantage in the European IVD market.

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