IFU-Anatomie

Anatomy of an IVD Reagent Package Insert

Interactive Document Dissection: From Reagent Name to Performance Data – Every Section Under the Microscope

Product identification includes the reagent name, catalog number, lot designation (lot number), expiry date, UDI-DI, as well as package size and presentation form. For reagent kits, all individual components are listed with their respective volumes and concentrations. This information must match the data on the outer packaging and primary container.

Challenge

Reagent names frequently consist of a combination of analyte name, method abbreviation, and brand designation (e.g., "Troponin I High-Sensitivity STAT Assay"). While the brand name is not translated, method designations like "STAT" (Short Turn-Around Time) need to be clarified in some languages. Concentration specifications like "5 x 10 mL" must be uniformly formatted across all languages.

Solution with manualworks

manualworks automatically detects and locks brand names and catalog numbers against translation. Simultaneously, analyte designations are validated against IUPAC and IFCC nomenclature. Concentration specifications and volumes are treated as protected numeric units that are only adapted in their formatting to the target language.

Annex I, Chapter III, Section 20.1 of IVDR 2017/746 requires that the label bear the name or trade name of the product, details allowing unambiguous identification of the product, and the contents of the package.

Frequently Asked Questions

How does translating an IVD package insert differ from a standard medical device IFU?+

IVD package inserts contain a unique mix of laboratory chemistry terminology, statistical performance data, and clinical-diagnostic language. While a medical device IFU primarily contains surgical or clinical instructions, IVD reagents require precise translation of analytical sensitivity and specificity, cross-reactivities, and interference factors. The IVDR 2017/746 also imposes specific requirements for performance evaluation that must be correctly presented in all languages.

Which standards are particularly relevant for IVD package inserts?+

The most important standards are EN ISO 18113-1 through EN ISO 18113-5 (In vitro diagnostics – Information supplied by the manufacturer), EN ISO 17511 (Metrological traceability of values for calibrators and control materials), and EN ISO 15223-1 (Symbols for medical devices). Additionally, the requirements of IVDR 2017/746 apply, particularly Annex I Chapter III. manualworks integrates the terminology of these standards directly into the translation workflow.

Can performance data in IVD package inserts be machine translated?+

Purely machine translating performance data is strongly discouraged. Statistical data such as sensitivity, specificity, confidence intervals, and reference ranges require the highest numerical precision and correct interpretation of the underlying studies. manualworks uses machine translation as a starting point but automatically protects numerical values from alteration and flags performance data sections as mandatory review segments.

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