MDR Article 10(11) requires the manufacturer to supply the label, instructions for use, implant card, and any other Section 23 information in the official Union language(s) determined by each Member State where the device is made available. The MDR sets no single EU-wide language; each Member State sets its own, and most require the national language for anything a lay person reads. A startup launching in five countries does not automatically need 24 languages, but it usually needs more than five. The practical answer for a resource-constrained startup is to plan market entry one country at a time, confirm each Member State's actual language requirement in writing, exploit the electronic IFU regulation where the device qualifies, and run translation inside a documented QMS process so every language version is under version control.

By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.

TL;DR

  • MDR Article 10(11) makes the manufacturer responsible for the language(s) of all information supplied with the device under Section 23 of Annex I, and delegates the choice of language to each Member State.
  • Five target countries is not the same as five languages and not the same as 24. Some Member States require two or three official languages; some accept English for professional users; some require the national language for everything.
  • The language obligation covers the label, the instructions for use, the implant card where applicable, and any accompanying patient information — not only the IFU.
  • Professional-use and lay-use devices are treated differently by many Member States. A device used exclusively by trained healthcare professionals can, in some countries, ship with English-only IFUs; a device used by patients at home almost always needs the national language.
  • Electronic IFU under Commission Implementing Regulation (EU) 2021/2226 reduces the paper translation burden for qualifying devices, but it does not remove the language obligation itself.
  • Translation is a QMS process. Every language version has to be under document control, verified, and re-verified when the source changes.

Five countries, five languages, twenty-four languages — none of those are right

A startup CE-marks a device and decides the first launch is Germany, Austria, the Netherlands, Belgium, and France. Five countries. The founder assumes five languages. The regulatory consultant walks it through the next day. Germany: German. Austria: German. Netherlands: Dutch. Belgium: Dutch for Flanders, French for Wallonia, German for the small German-speaking community — in practice the label carries all three. France: French. That is four languages and a Belgian trilingual carton that is effectively a fourth SKU.

Then someone asks "shouldn't we just translate into all 24 EU languages now and be done?" That is the other trap. Every language version has to be maintained and re-verified when the source document changes. A startup that translates into 24 languages before entering 24 markets is paying for 20 maintenance burdens it does not yet need.

The right answer is between the traps — translate what current markets require, in entry order, with a process that makes each next translation cheaper.

What MDR Article 10(11) actually says

Article 10(11) of Regulation (EU) 2017/745 sets the language obligation. The manufacturer must ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language or languages determined by the Member State in which the device is made available to the user or patient. Particulars on the label must be indelible, easily legible, and clearly comprehensible to the intended user or patient. (Regulation (EU) 2017/745, Article 10, paragraph 11.)

Three things follow. First, the obligation is the manufacturer's — not the distributor's or importer's. Second, the scope is Section 23 of Annex I, covering the label (23.2), the implant card and accompanying information (23.3), and the IFU (23.4). A startup that translates the IFU but leaves the carton label in English is not compliant. Third, the choice of language is delegated to each Member State; the MDR itself does not list languages per country. The default for lay-user information is the national language; the treatment of professional-user information varies.

Professional use versus lay use — the quiet split

Several Member States distinguish between devices used exclusively by trained healthcare professionals and devices used by patients or other lay users.

For lay-use devices — anything a patient uses at home, anything implanted and accompanied by patient information — the national language is the floor in almost every Member State. A consumer blood glucose meter in Finland needs Finnish, in Greece needs Greek, in Portugal needs Portuguese. English-only is not an option.

For professional-use devices used exclusively in hospitals by trained healthcare professionals, some Member States accept English as the sole language for the IFU. The Nordic countries, the Netherlands, and a handful of others take this approach. Others, including France, Italy, and Spain, require the national language regardless.

This split matters for startup economics. A startup selling a professional-use surgical device into the Nordics plus the Netherlands may legally ship English-only IFUs into all of them, provided each Member State's rule confirms it. The same startup selling into France, Italy, and Spain has to translate into French, Italian, and Spanish regardless.

Build a country-by-country language matrix before committing to a market entry order, and confirm each Member State's rule in writing with a local regulatory contact or the competent authority. Rules change, and interpretations differ.

The electronic IFU lever

Commission Implementing Regulation (EU) 2021/2226, amended by (EU) 2025/1234, sets out the conditions under which a manufacturer may provide instructions for use in electronic form instead of on paper. Where it applies — primarily for fixed installed devices, implantable and active implantable devices used exclusively by healthcare professionals, and certain software — eIFU reduces the packaging and printing burden. (Commission Implementing Regulation (EU) 2021/2226.)

eIFU does not remove the language obligation from Article 10(11). The electronic IFU still has to be provided in the Member State's required language(s). What it changes is the mechanics of delivery: instead of a printed booklet in every box, the manufacturer hosts the IFU and serves the correct language version based on the market. Adding a new language is a website update, not a print run. Updating the IFU is a new PDF upload, not a recall. For a qualifying device, eIFU turns a linear translation cost into a near-fixed one. See Electronic Instructions for Use (eIFU) under the MDR for qualification criteria and hosting requirements.

The label itself is not in scope of the eIFU regulation. The carton label has to carry the required indelible particulars in the required language(s) regardless of how the IFU is delivered.

A worked rollout for a five-country launch

Take a concrete example. A startup has CE-marked a Class IIa professional-use device and plans a five-country rollout in this order: Germany, Austria, Netherlands, France, Belgium.

  • Wave 1 — Germany and Austria. Both require German. One language, two markets. Label, IFU, and implant card (if applicable) in German. First wave ships.
  • Wave 2 — Netherlands. Dutch required for labels. For professional-use IFUs, confirm in writing whether the competent authority accepts English. Translate the label into Dutch; keep the IFU in German plus English as appropriate.
  • Wave 3 — France. French required regardless of professional use. Both label and IFU need French translation.
  • Wave 4 — Belgium. Belgium requires Dutch, French, and German. By this point the startup already has all three from earlier waves — no new translation, just a Belgium-specific label layout.

Five countries, three languages translated, staged across four waves. Each wave funds the next. No translation into other EU languages until there is a committed market entry.

Translation as a QMS process — the playbook

Translation is not a vendor contract. It is a controlled process under the QMS. EN ISO 13485:2016+A11:2021 treats translated documents as controlled documents — every language version is controlled, every version change triggers re-verification of every language version, and every translation vendor is a qualified supplier under clause 7.4.

  • One source of truth. Maintain the source IFU, label, and implant card in one language. Every translated version derives from the source at a specific version number. When the source updates, every translation updates in lockstep.
  • Qualified translators. Qualify the translation vendor as a supplier under ISO 13485. Medical device translation is a specialization; general translation agencies are not automatically qualified.
  • Native-speaker regulatory review. Every language version is reviewed by a native speaker who understands the regulatory domain, not only the language.
  • Back-translation for high-risk content. For warnings, contraindications, and patient-facing instructions on implant cards, a back-translation and reconciliation step catches meaning drift.
  • Version control per language. Every language version has its own version number tied to the source version. No language version is "current" until re-verified against the new source.
  • One-time terminology glossary. Build the glossary once as a controlled document and reuse it across every translation wave. The first wave is slow; every subsequent wave is faster.
  • Traceable records. For every language version: who translated, who reviewed, what source version, what findings, what corrective actions. This is the evidence a Notified Body will ask for on audit.

See MDR labeling requirements for the content side of what the label must carry, and Instructions for use under MDR for the structural requirements that the translation has to preserve.

Reality Check — Where do you stand?

  1. Do you have a written, country-by-country language matrix for every Member State you plan to enter, confirmed in writing with a local regulatory source?
  2. Is your market entry order sequenced so that each wave re-uses translations from previous waves where possible (DE/AT together, NL/BE overlap, and so on)?
  3. Have you confirmed whether your device is professional-use or lay-use, and whether any Member State on your list accepts English for professional-use IFUs?
  4. If your device qualifies for eIFU under Implementing Regulation (EU) 2021/2226, have you decided whether to use it, and do you have the hosting, archiving, and language-switching infrastructure in place?
  5. Is translation under document control in your QMS, with qualified translator suppliers, native-speaker regulatory review, and version-per-language traceability?
  6. When the source IFU changes, does your change control process trigger re-verification of every language version, or do the translations drift out of sync?
  7. Does your label layout accommodate multi-language Member States like Belgium without cramming the required indelible particulars into unreadable fonts?

Frequently Asked Questions

Does MDR require all 24 official EU languages on every device? No. MDR Article 10(11) requires the language(s) determined by each Member State where the device is made available. A startup that sells in only three Member States needs only the languages those three Member States require — not all 24. Translation obligation scales with market footprint, not with the number of EU official languages.

Can a startup ship English-only IFUs in the EU? Only in narrow circumstances. Some Member States accept English for devices used exclusively by trained healthcare professionals, under conditions the Member State sets. For lay-use devices — anything a patient uses or reads — the national language is required in nearly every Member State. Confirm each target Member State's rule in writing before entry; do not assume English is acceptable.

Does the language obligation cover the label or only the IFU? Both, and more. MDR Article 10(11) points to Section 23 of Annex I, which covers the label (Section 23.2), the implant card and accompanying information (Section 23.3), and the instructions for use (Section 23.4). The language requirement applies to all of these, not only the IFU.

Does using an electronic IFU remove the translation obligation? No. Commission Implementing Regulation (EU) 2021/2226 allows electronic IFUs for qualifying devices, but the eIFU still has to be provided in the Member State's required language(s). What eIFU changes is the mechanics of delivery and version control, not the language obligation itself.

Who is legally responsible for the translation being correct — the manufacturer or the distributor? The manufacturer. MDR Article 10(11) places the obligation on the manufacturer to ensure the device is accompanied by the required information in the required language. Distributors and importers have their own verification obligations under Articles 13 and 14, but the responsibility for the translation being correct sits with the manufacturer.

How should a startup sequence market entry to minimize translation cost? Group markets that share a language (Germany and Austria for German; Belgium and Netherlands for Dutch; Belgium, France, Luxembourg for French). Launch the first wave into markets that share a language, then stage new-language waves so that the revenue from earlier waves funds the translation cost of later waves. Avoid translating into any language until there is a committed market entry date for a Member State that requires it.

Is translation a one-time cost? No. Every time the source label or IFU changes, every language version has to be updated and re-verified. This is why translation has to live inside the QMS as a controlled process, not as a one-off vendor purchase.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 10(11) (language of information supplied with the device) and Annex I Chapter III Section 23 (label, implant card, instructions for use). Official Journal L 117, 5.5.2017.
  2. Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use of medical devices, as amended by Commission Implementing Regulation (EU) 2025/1234 of 25 June 2025.
  3. EN ISO 13485:2016+A11:2021 — Medical devices — Quality management systems — Requirements for regulatory purposes, clause 4.2 (documentation) and clause 7.4 (purchasing), applied to controlled translation.

This post is part of the Technical Documentation & Labeling cluster in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. Multi-language labeling is the place where regulatory obligation, market strategy, and startup economics collide — sequence the markets, re-use what you translate, and run every language version under the same document control the rest of the QMS demands.