Every market you enter adds a language bill. The EU alone can require up to 24 official languages for labels and instructions for use. The FDA requires English. Switzerland wants German, French and Italian. Translation is not a line item you add at the end — it is a regulated activity with audit trails, qualified translators, and error categories that can block your registration.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • MDR Article 10(11) requires manufacturers to provide information with the device in official Union language(s) determined by each Member State where the device is made available.
  • For most EU markets, that means labels, instructions for use, implant cards, patient-facing information and the EU Declaration of Conformity must be translated into the national language.
  • Translator qualifications matter: regulators and notified bodies expect medical translators with evidence of competence, a documented process, and a review step by a second qualified person.
  • Translation cost scales roughly linearly with markets. A lean startup can realistically budget EUR 0.12 to 0.25 per word for medical translation, plus review and layout.
  • The most damaging errors are not typos: they are mistranslated intended purpose, warnings weakened by context, and symbols replaced with words that change meaning.

Why this matters

The first time a founder sees a realistic translation quote, the reaction is usually silence. A single class IIa device with 60 pages of IFU, a quick reference guide, packaging, and a patient leaflet can reach 25,000 source words. Multiply by ten EU languages and you are looking at a translation program that rivals the cost of your first clinical investigation site.

The reason it catches founders off guard is simple: translation is invisible in the regulation until you are placing on market. You read Article 10, you plan your technical documentation, you budget for your notified body — and language is a footnote. Then your first distributor in Poland asks for the IFU in Polish, your Austrian hospital customer asks for German, and your Italian partner wants everything including the website claims. Suddenly translation is the critical path.

This post gives you a realistic picture of what must be translated, by whom, with what quality process, and what it costs. It is the boring infrastructure layer of international market access, and it is where avoidable delays hide.

What MDR actually says

The core obligation sits in MDR Article 10(11): manufacturers must ensure that the device is accompanied by the information required under Annex I Section 23 in an official Union language or languages determined by the Member State in which the device is made available to the user or patient.

The practical effect is that language competence is a national-level decision. Germany can require German. France can require French. Finland can require Finnish and Swedish. There is no single EU-wide language rule. A handful of Member States accept English for professional-use devices used exclusively by healthcare professionals, but this is the exception, not the rule, and it is narrowly defined.

Annex I Chapter III Section 23 specifies what information must be provided: the label and the instructions for use, including identification, safety and performance information, warnings, precautions, residual risks, and disposal. This is the scope of what must be translated. It is not only the IFU. It includes:

  • The label on the device and its packaging
  • The instructions for use (or eIFU where permitted under Implementing Regulation (EU) 2021/2226 as amended)
  • The implant card (for implantable devices, MDR Article 18)
  • The SSCP (Summary of Safety and Clinical Performance) for class III and implantable devices, MDR Article 32
  • The EU Declaration of Conformity (typically required in the language of the Member State of placing on market)
  • Patient information leaflets where applicable

Outside the EU the rules shift completely. The US FDA requires labeling in English. The UK currently accepts English for Great Britain. Switzerland requires German, French and Italian. Canada requires English and French for most devices. Japan requires Japanese. Brazil requires Portuguese with notarised translations. Every market is its own decision.

A worked example

Take a class IIa SaMD that has a web interface, a patient-facing mobile app, and a clinician dashboard. The manufacturer, a six-person startup, targets Germany, Austria, the Netherlands, France, Italy and Spain in year one.

The source content audit looks like this: - Product UI strings (patient app): 4,200 words - Product UI strings (clinician dashboard): 3,100 words - IFU: 11,500 words - Quick start guide: 1,800 words - Labels and packaging text: 900 words - EU Declaration of Conformity template: 400 words - In-app warnings, error messages, consent screens: 2,600 words

Total: 24,500 words.

Language plan: - Germany and Austria: German (one translation, reused) - Netherlands: Dutch - France: French - Italy: Italian - Spain: Spanish

That is five target languages. At an average all-in rate of EUR 0.20 per source word for qualified medical translation with independent review, plus layout and QA, the raw cost is 24,500 x 0.20 x 5 = EUR 24,500. Add layout, in-country review, and a change control buffer for the first updates after launch, and the realistic program cost lands between EUR 30,000 and EUR 40,000 for year one.

That is a serious number for a seed-stage company, and it is before you add translation for any PMCF surveys, customer support content, or marketing. The subtract-to-ship question is: which of those six markets are you actually ready to serve on day one, and which can wait until after first revenue?

The Subtract to Ship playbook

Step 1: Freeze your source English before you translate anything. The most expensive mistake is translating a moving target. Get your IFU, labels, UI strings and warnings through a full internal review and into version control under document control per MDR Article 10(9). Every change after that has a translation cost.

Step 2: Use symbols ruthlessly. EN ISO 15223-1 provides harmonised symbols that replace translated text on labels. Every symbol you use correctly is a word you do not translate in every language forever. Date of manufacture, expiry, manufacturer, batch, sterilisation method, single-use, caution, consult IFU — all symbolised. The label text that remains is smaller and easier to manage.

Step 3: Pick languages by revenue, not ambition. MDR Article 10(11) requires translation in the Member States where you place on market. If you do not place on market in Portugal, you do not need Portuguese. The instinct to "cover Europe" kills translation budgets. Start with the countries where you have signed distribution, hospital pilots, or a clear commercial path, and add the rest after first orders.

Step 4: Qualify your translator as a supplier. Under EN ISO 13485:2016+A11:2021 clause 7.4 and MDR Article 10(9), translation is an outsourced process affecting product conformity. That means your translation provider sits in your supplier list with a qualification record. Require evidence of medical translation experience, ISO 17100 compliance if possible, and a documented two-step process (translation plus independent review by a second qualified linguist). Keep the evidence.

Step 5: Build a terminology glossary once. Your intended purpose, your warnings, your device name, your claims — all of these need consistent terminology across languages. A bilingual glossary built once, reviewed by a clinician in the target market, saves weeks of rework and prevents the single most dangerous category of error: warnings that lose force in translation.

Step 6: Plan for in-country review. A native-speaking clinician or regulatory contact in the target market reviews the final layout before print or release. This catches cultural and clinical phrasing issues that a translator working from source cannot catch. Budget for it.

Step 7: Version control everything. Every translated file has the same document ID, version and approval as the source. Changes trigger re-translation of the changed segments (translation memory makes this cheap). This is where most startups lose control — they translate once, update the English, and forget to propagate.

Step 8: Use eIFU where permitted. Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234 allows electronic instructions for use for defined device categories and professional users. eIFU does not remove the translation obligation, but it reduces printing, physical distribution and versioning cost. Check whether your device qualifies.

Reality Check

  1. Do you know, for each market you intend to enter, which documents must be translated and into which language(s)?
  2. Is your English source content frozen under document control before translation begins?
  3. Have you qualified your translation provider as a supplier under your QMS, with documented evidence of medical translation competence and a two-step review process?
  4. Do you have a bilingual terminology glossary reviewed by a clinician in each target language?
  5. Have you used EN ISO 15223-1 symbols on labels to minimise label text that must be translated?
  6. Do you have a process to propagate source changes to all translated versions with version control?
  7. Have you budgeted realistically — at least EUR 0.15 to 0.25 per source word all-in — for every target language in your plan?
  8. Do you have an in-country reviewer identified for each target market before first release?

Frequently Asked Questions

Is English sufficient for professional-use devices in the EU? Some Member States accept English for devices used exclusively by healthcare professionals, but this is a national decision, narrowly scoped, and not a rule you can rely on across the EU. Check the specific Member State requirement before assuming English suffices.

Do I need to translate the EU Declaration of Conformity? The Declaration must generally be provided in the language(s) required by the Member State in which the device is placed on market. Many manufacturers produce it in English plus each required national language.

Can I use machine translation for medical devices? Machine translation without qualified human post-editing and independent review is not acceptable for regulated content. Raw machine output introduces unacceptable risk in warnings, intended purpose and clinical terminology. Machine translation with qualified post-editing is acceptable if your process is documented and reviewed.

Does eIFU remove the translation obligation? No. Electronic instructions for use must still be provided in the required language(s) for each Member State. eIFU reduces printing and distribution cost, not translation cost.

Who is legally responsible if a translation is wrong? The manufacturer. You cannot delegate regulatory responsibility to the translator. Your supplier qualification, your review process and your document control are the evidence that you controlled the activity.

What is the single most dangerous translation error? Weakened or shifted warnings. A warning that is a command in English ("Do not use if…") can become a suggestion in translation. This is the error category that auditors and vigilance investigators take most seriously.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 10(11), Article 18, Article 32, Annex I Chapter III Section 23.
  2. Commission Implementing Regulation (EU) 2021/2226 as amended by (EU) 2025/1234 — Electronic instructions for use.
  3. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes, Clause 7.4.
  4. EN ISO 15223-1 — Medical devices — Symbols to be used with information to be supplied by the manufacturer.