In 2006–2007, at least 47 patients at a Berlin hospital received knee implants that were never meant for their procedure. The packaging of a U.S.-made prosthesis carried the English phrase “non-modular cemented.” A hospital employee rendered it in German as “zementfrei”—without cement. The wrong version went into the operating room. Corrective surgeries followed, along with multi-million-euro claims against both the hospital and the manufacturer. German law at the time required Instructions for Use to be in German but did not mandate translation of outer packaging labels; the FDA required English labeling for the U.S. market. The gap between those two rules, combined with an informal translation, produced a cascade of clinical and legal consequences that still appears in regulatory training materials today.
That episode is extreme, yet it is not isolated. Terminology inconsistencies, incomplete language versions, and uncontrolled glossaries continue to delay submissions, trigger Notified Body questions, and, in the worst cases, contribute to field actions. For companies bringing devices or pharmaceuticals across borders, translation is no longer a downstream localization task. It is a regulatory control point with direct effects on market access and patient safety.
What the Major Markets Actually Require
Under EU MDR Article 10(11) and the parallel provision in IVDR, manufacturers must supply the information set out in Annex I, Section 23—labels, packaging, and instructions for use—in the official language or languages determined by each Member State where the device is made available. There is no single EU-wide language list. The European Commission publishes country-by-country tables (most recently Revision 3 for MDR) that distinguish between professional-use and lay-user devices, and between labels, IFUs, implant cards, Declarations of Conformity, and field safety notices.
In practice this means German for Germany (with limited English flexibility for certain professional-use materials), French for France, Spanish for Spain, and so on. Several Member States accept English for professional-use IFUs or labels under defined conditions—Austria, Belgium, the Netherlands, Poland, Ireland, and Malta among them—but almost all require the national language for patient-facing materials. Ireland and Malta are the clearest exceptions where English can serve for both professional and lay users. Symbols from ISO 15223-1 can reduce the volume of text that needs translation, but any written warning or intended-purpose statement still falls under the language rules.
The FDA’s baseline under 21 CFR 801 is English for devices distributed in the United States. If any required statement appears in a foreign language, the entire set of required labeling elements must also appear in that language. Puerto Rico and certain territories allow Spanish as the predominant language. For submissions themselves, any non-English source document must be accompanied by a complete English translation and a signed accuracy statement. Health Canada requires bilingual English–French labeling for most devices marketed nationwide. Japan, China, Brazil, South Korea, and the Gulf states each maintain their own mandatory language and formatting rules for labels, IFUs, and registration dossiers. The practical result for a global launch is a language matrix that can easily exceed a dozen versions, each subject to its own readability, symbol, and update obligations.
Where Translations Most Often Fail
Three patterns appear repeatedly in warning letters, Notified Body findings, and post-market analyses.
First, terminology drift. The same clinical concept—contraindication, single-use, non-sterile, or a specific performance claim—receives different renderings across the IFU, packaging, software interface, and clinical evaluation report. When reviewers compare language versions, the inconsistencies surface as questions or deficiencies.
Second, incomplete coverage. A manufacturer translates the IFU for the five largest EU markets but overlooks the implant card, the Summary of Safety and Clinical Performance, or the graphic user interface of a connected app. Member State tables and national legislation treat these as separate obligations.
Third, process gaps. Translations performed outside the quality management system, without controlled translation memories, dual review by subject-matter linguists, or documented back-translation of critical safety text, leave no auditable trail. Under MDR and ISO 13485 expectations, the translation process itself becomes part of the technical documentation that Notified Bodies examine.
A 2017 FDA warning letter illustrated the pharmaceutical side of the same problem: an over-the-counter product’s labeling issues around the naming of an active ingredient contributed to dexamethasone being presented as hydrocortisone. The underlying cause was translation and nomenclature inconsistency rather than intentional misrepresentation.
Practical Controls That Reduce Risk
Successful programs treat regulatory translation as a controlled process rather than a vendor transaction. They maintain a single, versioned glossary of preferred terms aligned with the source technical file and with the terminology expected by each authority. They map every document type against the language requirements of the target markets before translation begins. They require linguists with demonstrated medical-device or pharmaceutical experience and subject the output to independent review, often including back-translation of high-risk segments such as warnings and contraindications. Layout and text-expansion checks are performed on the actual packaging and interface mock-ups so that German compound nouns or Arabic right-to-left scripts do not break legibility or symbol placement.
These steps do not eliminate cost, but they convert translation from a source of late-stage surprises into a predictable element of the regulatory timeline. Companies that integrate the language matrix into their design-history and technical-file processes routinely report fewer requests for additional information and shorter overall review cycles.
Looking Ahead
EUDAMED registration obligations, electronic IFUs, and the continued expansion of MDR/IVDR transitional provisions keep raising the bar for multilingual consistency. At the same time, markets outside Europe and North America are tightening their own documentation rules. The organizations that treat language as a core regulatory competence—rather than an afterthought—will move devices and medicines through approval pathways with fewer interruptions and with clearer evidence that the information reaching clinicians and patients is accurate.
Artlangs Translation has spent more than two decades supporting life-science and medical-device clients across these exact requirements. With coverage in over 230 languages, a network of more than 20,000 specialized linguists, and documented experience in regulatory dossiers, IFUs, labeling, and related technical content, the company has delivered projects that align with the language matrices of the EU, FDA, Health Canada, and multiple Asia-Pacific authorities. Beyond pure translation, its services extend to video localization, short-drama subtitle localization, game localization, multilingual dubbing for short dramas and audiobooks, and multilingual data annotation and transcription—capabilities that support the growing volume of digital and multimedia materials now accompanying medical products. Teams that need consistent, auditable multilingual support for registration and post-market materials regularly turn to providers with this depth of regulated-industry track record.
