IFU Translation for In Vitro Diagnostics
IVDR-compliant translations for the full spectrum of laboratory diagnostics
The IVD industry in transition: New regulation, new translation requirements
The In Vitro Diagnostic Regulation (IVDR 2017/746) has fundamentally changed the regulatory landscape for IVD manufacturers in Europe. With the shift from the list-based classification system of Directive 98/79/EC to the risk-based four-class system of the IVDR, significantly more products are now subject to stricter regulatory oversight. This has far-reaching consequences for the translation of instructions for use.
From Directive to Regulation: What changes for IFU translations
Under the old Directive 98/79/EC, many IVD products could be placed on the market without the involvement of a Notified Body. The IVDR tightens this considerably: Class B, C, and D products now require the involvement of a Notified Body, which also reviews the conformity of instructions for use. This means translations must not only be linguistically correct but must also demonstrably originate from a validated process.
Article 10(11) of the IVDR mirrors the MDR requirement: all information pursuant to Annex I Chapter III must be provided in the official language of the respective Member State. For IVD manufacturers distributing across Europe, this means translations into up to 24 official EU languages.
Special terminological challenges in the IVD industry
The instructions for use of IVD products differ significantly from those of other medical devices in both structure and content. They typically contain: information on test principles and analytical performance, detailed sample preparation and procedure instructions, information on interferences and cross-reactivities, performance data with statistical analyses, and information on calibration and quality control.
Each of these areas brings its own terminological challenges. While EN ISO 18113 defines requirements for the labelling of IVD reagents, implementing these in 24+ languages requires expertise that goes beyond pure linguistic competence. Terms such as "analytical specificity" or "limit of detection" have established translations in various languages that are not reliably covered by general-purpose dictionaries.
The special case of Companion Diagnostics and Class D products
Companion Diagnostics and other Class D products — such as blood grouping tests or tests for the detection of transmissible agents — are subject to the highest IVDR scrutiny level. Their instructions for use are particularly extensive and contain safety-critical information whose erroneous translation can directly impact patient diagnoses. A controlled, traceable translation process is not optional here — it is essential.
manualworks as a specialized platform for IVD translations
manualworks addresses the specific requirements of the IVD industry through a combination of domain-specific terminology databases, segment-based translation management, and automated revision detection. The platform enables IVD manufacturers to map the entire translation process — from source text creation through translation and subject matter review to regulatory approval — in a single system.
Through the integration of translation memories, recurring text modules — such as standard warnings or general sample preparation instructions — are automatically recognized and consistently reused. This is particularly valuable for IVD manufacturers with large product portfolios, where many instructions for use share similar structures and phrasings. The result is an IVDR-compliant translation process that accommodates both the regulatory requirements and the time and budget constraints of the IVD industry.
Frequently Asked Questions
What specific requirements does the IVDR place on IFU translations?+
The IVDR 2017/746 requires in Article 10(11) that instructions for use for IVD products be provided in the official language of each target market. Especially for Class D products (e.g., blood grouping tests, HIV diagnostics), safety-relevant information such as performance claims, test principles, and sample preparation must be linguistically precise. manualworks ensures this through domain-specific terminology databases and validated translation workflows.
How does manualworks handle the frequent updates to IVD instructions for use?+
IVD instructions for use are frequently updated — for example, when reagent compositions change, new performance data is available, or FSCA notices are issued. manualworks automatically identifies changed segments with each revision and creates targeted translation tasks. Unchanged sections are carried over from translation memory, so only the actual changes need to be translated. This significantly accelerates the revision process.
Does manualworks support the translation of IVD performance evaluation reports?+
manualworks is primarily designed for the translation of instructions for use and labeling documents. However, the platform can also manage supplementary documents such as performance evaluation report summaries, quick start guides, and safety notices. Shared terminology databases ensure that technical terms remain consistent across all document types.