Instructions for use (IFU) for medical devices, industrial equipment, and regulated products must be available in the official language or languages of each EU Member State where the product is placed on the market. Under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), translated IFU are not optional documentation — they are a legal condition for CE marking and market access. A translation error in an IFU is not merely a linguistic problem: it is a compliance failure that can delay certification, trigger corrective action requests, or expose the manufacturer to liability.
What EU Regulation Requires for IFU
The MDR and IVDR require that IFU be drawn up in the official language or languages of the Member State where the device is made available to the user. For manufacturers distributing across multiple EU countries, this means translations into German, French, Spanish, Italian, Polish, Dutch, and other languages depending on target markets.
Beyond language, the regulations specify mandatory content elements that must be present in every translated version:
- Full identification of the manufacturer and the authorised representative in the EU
- Intended purpose, contraindications, warnings, and precautions
- Instructions for installation, calibration, maintenance, and decontamination, as applicable
- Symbols conforming to ISO 15223-1
- Issue date or version identifier for traceability purposes
Notified bodies review the technical documentation file, which includes the IFU. Incomplete translations, inconsistent terminology, or missing mandatory warnings can delay or block certification.
Quality Requirements and Process for IFU Translation
Translating IFU for regulatory purposes requires a process that goes well beyond general document translation. The main requirements are:
Translators with specialist technical and regulatory expertise. ISO 17100:2015 sets the minimum requirements for professional translation services, including translator and reviewer qualifications. For medical device IFU, this means familiarity with medical terminology, applicable ISO standards (ISO 13485, ISO 14971), and EU regulatory vocabulary.
TEP process (Translation, Editing, Proofreading). Quality cannot be guaranteed without independent review by a second specialist. Errors that survive the translation stage and reach the final document can compromise end-user safety and the regulatory validity of the file.
Terminology management. IFU are part of a broader technical documentation set — design documentation, labelling, FSCAs. Terminological consistency across all documents is verified by notified bodies. Controlled glossaries and translation memories prevent inconsistencies between versions and updates.
Version control and traceability. Each translated version must correspond unambiguously to the approved source version. Any change to the source document requires a controlled update of all translations, with a documented change record.
Most Requested Languages for EU IFU Projects
The priority markets for manufacturers entering the EU vary by sector and commercial strategy. The most common language combinations in IFU projects include:
| Market | Required language(s) |
|---|---|
| Germany | German |
| France | French |
| Spain | Spanish (Castilian) |
| Italy | Italian |
| Portugal | European Portuguese |
| Brazil (ANVISA) | Brazilian Portuguese |
| Angola / Mozambique | European Portuguese or local variant |
| Poland | Polish |
| Netherlands | Dutch |
Manufacturers seeking pan-European distribution commonly commission projects involving 10 to 25 languages. In these cases, centralised project management — with a single provider coordinating all language versions — reduces the risk of inconsistencies and simplifies the technical documentation approval process.
Beyond the EU, markets such as Brazil (ANVISA) and the United States (FDA 21 CFR) have their own IFU requirements. Brazilian Portuguese, for instance, follows terminology conventions and regulatory register that differ significantly from European Portuguese — a distinction manufacturers frequently underestimate.
Common Errors That Compromise IFU Compliance
Experience in regulatory translation projects reveals recurring patterns of failure:
- Unreviewed machine translation. Machine translation tools produce terminology errors and omissions that go undetected without specialist review. ISO 18587 defines the post-editing process for machine-translated content — only when correctly applied does it provide acceptable quality assurance for regulatory contexts.
- Inconsistency with labelling. IFU and labels form part of the same technical file. Terminology divergences between the two are flagged during notified body audits.
- Missing safety warnings. Mandatory warnings that are omitted or softened in translation constitute direct non-compliance with the MDR or IVDR.
- Partial version updates. When a manufacturer updates the source IFU, it is common for only some language versions to be updated, creating inconsistencies across the technical file.
- Absence of a documented process. Notified bodies require evidence of the translation process — not just the final document. The absence of quality control records can lead to rejection of the technical documentation.
IFU Translation with M21Global
M21Global provides IFU and regulatory technical documentation translation for EU markets, Brazil, and other territories, following a process certified to ISO 17100:2015 (Bureau Veritas) and ISO 18587 for machine translation post-editing. With over 20 years of experience and more than 300 million words translated, the company delivers centralised management of multilingual projects, controlled terminology glossaries, and full version traceability — the elements that notified bodies verify in technical documentation files.
To begin the translation of your IFU or request a quote for a regulatory project, contact M21Global at m21global.com.
Frequently Asked Questions
Does IFU translation for medical devices require ISO 17100 certification?
The MDR and IVDR do not explicitly reference ISO 17100, but notified bodies assess the quality and process behind the translations in a technical documentation file. ISO 17100 certification demonstrates that the translation process meets minimum qualification and review requirements, which reduces the risk of non-compliance findings during audits.
How many languages are required to market a medical device across the EU?
The EU has 24 official languages. In practice, manufacturers translate IFU into the official languages of the Member States where the device is actually placed on the market. Pan-European distribution projects typically involve between 10 and 25 languages.
Can machine translation be used for medical device IFU?
Unreviewed machine translation is not suitable for IFU in regulatory contexts. ISO 18587 defines the post-editing process for machine-translated content by human specialists — when correctly applied and documented, this approach can be used in regulatory projects, but it requires specialist review and a documented process.
What happens if translated IFU contain errors identified by the notified body?
Errors in translated IFU typically result in corrective action requests that delay CE certification, or in rejection of the technical documentation file. In cases of serious non-compliance — such as missing safety warnings — the notified body may suspend the certification process entirely.
Is IFU translation for the Brazilian market (ANVISA) different from translation for EU markets?
Yes. Brazilian Portuguese and European Portuguese differ in technical terminology, register, and writing conventions. ANVISA has its own labelling and IFU requirements that differ from those under the MDR and IVDR. A separate translation and adaptation process is required for each market.
