IVDR Translation Requirements: What In Vitro Diagnostic Manufacturers Need to Know

Key Takeaways

• IVDR (EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices) replaced the previous IVD Directive (98/79/EC) with a significantly stricter regulatory framework. Full application has been phased in by device risk class.
• Like EU MDR, IVDR requires that labels and Instructions for Use (IFUs) be available in the official language or languages of each EU member state where the device is placed on the market.
• IVDR introduced a new risk classification system for IVDs — Class A, B, C, and D — replacing the previous self-declaration/Annex II list system. Higher-class devices face stricter documentation and translation requirements.
• The technical documentation required for IVDR conformity assessment includes performance studies, risk management files, and post-market surveillance plans — all of which may require translation when sourced from non-EU markets.
• Translation errors in IVD labelling and IFUs carry direct patient safety implications — incorrect test instructions, sample handling requirements, or result interpretation information affects diagnostic accuracy.

The EU Regulation on In Vitro Diagnostic Medical Devices (IVDR 2017/746) represents the most significant regulatory change for the IVD industry in Europe in over two decades. While it shares structural similarities with EU MDR 2017/745, IVDR applies specifically to in vitro diagnostic devices — tests, reagents, calibrators, control materials, instruments, and software used for examining specimens derived from the human body.

For IVD manufacturers, IVDR brings substantially more rigorous documentation requirements, a new risk classification system, and the same language obligations as EU MDR for labelling and IFUs. This guide covers the translation requirements that arise from IVDR and what manufacturers need to plan for.

What IVDR covers

IVDR applies to in vitro diagnostic medical devices — devices intended to be used in vitro for the examination of specimens derived from the human body, including blood, urine, tissue, and other biological materials. This includes:

• Clinical chemistry analysers and reagents
• Haematology analysers
• Immunoassay systems
• Microbiology and molecular diagnostics
• Genetic testing
• Point-of-care testing devices
• Self-test devices (home blood glucose monitors, pregnancy tests, HIV self-tests)
• Companion diagnostics
• Software used in IVD analysis and result reporting

Instruments, reagents, and software used together as a system are assessed as a system under IVDR.

IVDR risk classification

IVDR introduced a new four-class risk system for IVDs, replacing the previous binary classification under the IVD Directive:

Class A — lowest risk. Includes general laboratory instruments not intended for a specific diagnostic purpose, and specimen receptacles. Can self-certify with a quality management system.

Class B — moderate individual risk, low public health risk. Includes most routine clinical chemistry and haematology tests. Requires involvement of a Notified Body only for the quality management system.

Class C — high individual risk or moderate public health risk. Includes tests for sexually transmitted infections, tests used in blood bank screening, and tests for congenital disorders. Requires Notified Body review of technical documentation.

Class D — highest risk. Includes tests for life-threatening blood-transmissible diseases (HIV, hepatitis B, hepatitis C) and tests for rare but serious diseases where false results have severe consequences. Requires the most intensive Notified Body scrutiny, including batch release testing for some devices.

The classification of a device determines the extent of Notified Body involvement and the volume of technical documentation required. For Class C and D devices, this documentation — including performance study reports, risk management files, and clinical evidence — may originate in multiple languages and require translation for the conformity assessment process.

Labelling and IFU language requirements under IVDR

Article 10(11) of IVDR requires that the label, outer packaging, and instructions for use be written in the official language or languages of the EU member state or states where the device is made available to the user or patient.

This is the same language obligation as EU MDR, and the same practical implications apply:

• A device distributed across all 27 EU member states requires labelling in up to 24 official EU languages
• IFUs for devices intended for self-testing (home use) must be written in plain, accessible language in each required language — the readability requirement is more demanding than for professional-use devices
• Labels and IFUs must be reviewed for accuracy in each language by qualified reviewers who understand both the target language and the technical subject matter

For self-test devices — the category that includes home blood glucose monitors, pregnancy tests, and HIV self-tests — the IFU language requirement carries additional weight. These devices are used by non-medical users who rely entirely on the IFU for safe and accurate use. Unclear, inaccurate, or poorly translated instructions directly affect test performance and result interpretation.

Technical documentation translation under IVDR

IVDR requires manufacturers to prepare and maintain comprehensive technical documentation covering the device's design, performance, safety, and post-market surveillance. For Class C and D devices, this documentation is reviewed by a Notified Body as part of the conformity assessment.

Technical documentation that originates in a language other than the working language of the Notified Body — typically English — must be translated. Key documents that may require translation include:

Performance studies — clinical performance studies, analytical performance data, and reference interval studies conducted outside the EU or in non-English-speaking countries. These studies form the core of the clinical evidence required for Class C and D devices.

Risk management files — risk analysis and risk management documentation prepared under ISO 14971. Where the risk management process is documented in the manufacturer's working language, translation into English (or the Notified Body's working language) is required.

Post-market surveillance reports — IVDR requires periodic summary technical documentation (PSTD) for Class A and B devices and periodic safety update reports (PSUR) for Class C and D devices. Where post-market data is gathered in local languages — complaint records, vigilance reports, literature searches — translation into the reporting language is required.

Supplier and raw material documentation — for Class D devices in particular, manufacturing process documentation and quality management records from component suppliers may require translation.

IVDR and companion diagnostics

Companion diagnostics — IVDs used to select patients for a specific targeted therapy — occupy a specific position under IVDR. A companion diagnostic used with a medicinal product must be assessed in coordination with the assessment of the medicinal product by the EMA. This coordination requirement means that labelling and technical documentation for companion diagnostics must meet the language requirements of both IVDR and the applicable medicinal product regulations.

Translation of companion diagnostic documentation therefore intersects with pharmaceutical translation requirements — a specialist area requiring translators with expertise in both IVD regulation and clinical pharmacology.

Common translation challenges in IVDR compliance

Terminology precision — IVD documentation uses highly specific analytical and clinical terminology. Sensitivity, specificity, positive predictive value, negative predictive value, limit of detection, and limit of quantification all have precise meanings that must be translated exactly. Approximations or non-standard terminology in translated performance documentation will be identified during Notified Body review.

Self-test IFU plain language — for self-test devices, IVDR requires that IFUs be written in language that a lay user can understand. This means translating not just the words but the readability level — a technically accurate IFU written at a clinical reading level does not meet the plain language requirement. Each language version must be assessed for readability as well as accuracy.

Volume management — for Class C and D devices distributed across multiple EU markets, the translation volume across all required languages for both labelling and technical documentation is substantial. Managing this through a single agency with a coordinated translation memory ensures terminology consistency across all language versions.

Global LTS provides medical device translation services for IVDR compliance, including IFU translation across all EU official languages, technical documentation translation for Notified Body submissions, and multilingual DTP for print-ready labelling. Contact us to discuss your IVDR translation project.

For related reading, see our guides on medical device labelling translation and FDA translation requirements for medical devices.