Medical device translation covers the documents needed for the use, labelling and regulatory compliance of medical devices and in vitro diagnostic (IVD) products. Accurate, compliant translation into the language of the country where the device is used is a legal requirement in most markets, and a single ambiguous instruction in a user manual can directly affect the safety of both patient and user. Below you will find which documents are translated, which rules they fall under and what the translation has to get right.
Medical device legislation requires the information needed for safe use to be provided in a language the user understands. In the European Union this means submitting documents in the official language of every member state where the device is sold; Türkiye applies a Medical Device Regulation aligned with the European legislation. Translation is therefore not an afterthought to marketing but an integral part of the CE conformity process and the market-entry file.
Medical device documentation speaks to different readers, from the person using the device to the regulator.
The instructions for use are the most critical document, describing safe and correct use: intended purpose, warnings, contraindications, step-by-step procedures and maintenance. The translation must be technically accurate and terminologically consistent, yet written at a level suited to the target user — physician, nurse or patient.
Labels carry mandatory information in a limited space and therefore rely heavily on standard symbols. The symbols used on medical device labels are defined in ISO 15223-1 and replace text in most countries. The translator needs to know which information is conveyed by symbol and which by text, and must not introduce a single inconsistency.
Device software and on-screen text are short, space-limited and context-dependent. A menu item or warning that is mistranslated or too long may not fit the screen or may mislead the user, which is why UI translation requires the strings to be checked in context on the actual screen.
The technical file is the body of documents proving the device’s regulatory compliance; the declaration of conformity is the manufacturer’s formal commitment, and the clinical evaluation is the evidence of safety and performance. These documents are addressed to the regulator and the notified body; their translations must be precise, consistent and fully traceable to the source.
User training and marketing content use a freer register, but within limits: every claim about the device must be consistent with its approved intended purpose and with the technical file. An exaggerated statement in marketing copy can become a regulatory problem.
In Europe, medical devices fall under the Medical Device Regulation (MDR — (EU) 2017/745) and in vitro diagnostics under the IVDR ((EU) 2017/746). These frameworks require many documents to be provided in the official language of every EU member state where the device is sold; unique device identification (UDI) and post-market surveillance are part of the same legislation. Accurate, consistent translation is therefore an integral part of the CE conformity process.
Because medical device texts are both technical and regulated, terminology governance and consistency are essential; an instruction that affects user safety leaves no room for ambiguity. A sound process rests on translation memory, approved glossaries and editing by an independent editor, with back-translation added where needed. UI strings are additionally checked in context.
The problems encountered most often are: using different terms in the IFU and on the label; translating UI strings without regard to screen limits, so that they are truncated; translating information already conveyed by a symbol into text and creating a contradiction; making marketing claims that exceed the approved intended purpose; and failing to update translations when the device design changes. Each creates a safety risk or a conformity issue.
Specialising in medical translation for over thirty years, Mirora — ISO 9001 certified, with an ISO 17100-aligned workflow — is a translation partner medical device manufacturers rely on.
Legislation requires the information needed for safe use to be provided in the user’s language; this is part of the conformity process.
MDR is the European Medical Device Regulation; IVDR is the regulation for in vitro diagnostic devices. Both require documents in the relevant official languages.
Instructions for use (IFUs), labels, device software and UI, the technical file, the declaration of conformity, the clinical evaluation, and training and marketing materials.
Symbols under ISO 15223-1 replace text in most countries and are not translated; what matters is knowing which information is conveyed by symbol and which by text, and keeping them consistent.
Strings must fit limited space and must not mislead the user, so they are checked in context on the actual screen.
Consistent terms across all of a device’s documents are required for both user safety and regulatory compliance, and are maintained with approved glossaries and translation memory.
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