Can I use English only on a medical device label in the EU?

Only where the relevant Member State permits it. Several Member States accept English for devices intended exclusively for professional users while requiring the national language for lay users and patients, and the Commission encourages that approach where safe use is not compromised. It is a national decision, not an EU-wide allowance, and it must be checked country by country before artwork is finalised.

Does the EU declaration of conformity have to be translated?

Yes, where a Member State requires it. MDR Article 19(1) says the declaration must be translated into an official Union language or languages required by the Member State or States in which the device is made available. It is a separate obligation from the label, and the required languages may differ from the label languages in the same country.

Is MDR Article 41 the rule for label and declaration of conformity language?

No. Article 41 is headed Language requirements, but it applies to the documents used for designating and assessing notified bodies under Articles 38 and 39. The label and instructions for use are governed by Article 10(11) with Annex I Section 23, and the declaration of conformity by Article 19(1). Citing Article 41 for labelling is a common but consequential error.

Can electronic instructions for use replace translated paper IFU?

Not as a way of avoiding translation. Regulation (EU) 2021/2226 allows electronic instructions only for implantable and active implantable devices, fixed installed devices, devices with a built-in display and software, and only where use is exclusively by professional users. Article 5(11) still requires the website version in the language the Member State determines, and paper must be supplied free within seven calendar days on request.

Is there an official EU list of national language requirements?

Yes. DG SANTE publishes an overview of language requirements for manufacturers of medical devices on health.ec.europa.eu, with separate MDR and IVDR tables covering label and IFU, implant card, declaration of conformity, field safety notice, conformity assessment documents and user interfaces. The Commission states it does not take responsibility for its correctness and that national law takes precedence, so verify against the cited national instrument.

Who is responsible if a distributor translates the instructions for use?

Translating the instructions for use is an activity regulated by MDR Article 16, which brings quality management system and notification obligations for the distributor or importer doing it. The manufacturer remains responsible for the Article 10(11) obligation and for the accuracy of the information supplied, so the arrangement should be documented before a competent authority asks about it.

Medical Device Label Language Requirements Under the EU MDR

Q: What language must a medical device label be in for the EU?

There is no single EU answer. MDR Article 10(11) requires the Annex I Section 23 information to be supplied in an official Union language determined by the Member State in which the device is made available to the user or patient. Each Member State makes that determination in its national implementing law, so a device sold across the Union may need several language versions of the same label.

7 days ago

7 min read

The medical device label language requirements under Regulation (EU) 2017/745 have a single, uncomfortable answer: the language is decided by each Member State in which the device is made available, not by the EU. There is no one European language for a label or for instructions for use. MDR Article 10(11) requires the manufacturer to supply the Annex I Section 23 information in "an official Union language(s) determined by the Member State in which the device is made available to the user or patient", so one device sold in six countries can face six separate national decisions.

This article covers only which language the text must be in. What the label must contain is covered in medical device labelling requirements, and the symbols that spare you some translation in medical device symbols.

Medical device label language requirements begin with MDR Article 10(11)

Article 10(11) is the operative provision. Its first sentence sets the language rule, its second the quality rule: "Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient."

Three points follow. The obligation sits with the manufacturer, even though importers and distributors must verify it under Articles 13 and 14. The trigger is where the device is made available, not where it is manufactured or where the notified body sits. And the Member State chooses, so the manufacturer's preference is legally irrelevant.

Article 10(14) adds a parallel duty aimed at regulators: documentation demonstrating conformity must reach a competent authority "in an official Union language determined by the Member State concerned". Under Article 11(3) your authorised representative carries the same duty for the documents held under the mandate.

Annex I Chapter III, Section 23.1 and what "comprehensible" adds

Annex I Chapter III opens Section 23 with the general obligation: "Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate." Section 23.1(a) then makes comprehension a design input: "In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams."

This is where medical device label language requirements stop being a procurement question and become a safety question. A grammatically correct Latvian translation pitched at a clinical register that a lay self-tester cannot follow does not satisfy Section 23.1(a), and market surveillance authorities do read it that way. Translation control, back-translation and readability evidence therefore belong in the technical documentation.

Section 23.1(f) is the hook for electronic instructions: "Instructions for use may be provided to the user in non-paper format (e.g. electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012 or in any subsequent implementing rules adopted pursuant to this Regulation." Those subsequent rules are now Commission Implementing Regulation (EU) 2021/2226.

The declaration of conformity, the implant card and the field safety notice

The EU declaration of conformity has its own language rule, in Article 19(1) and not Article 41: "The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available." That is a translation obligation in the plural, so a single English declaration is not automatically enough. The document itself is covered in the EU declaration of conformity.

Article 41 does carry the heading "Language requirements", but it governs the documents used to designate and assess notified bodies: "All documents required pursuant to Articles 38 and 39 shall be drawn up in a language or languages which shall be determined by the Member State concerned." Citing Article 41 for labelling or for the declaration of conformity is a common and consequential misreading; it reaches neither.

For implantables, Article 18(1) requires the patient information to be "written in a way that is readily understood by a lay person" and "stated in the language(s) determined by the concerned Member State". For safety communications, Article 89(8) provides that "The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken."

Which document, which legal basis, who decides the language

The MDR spreads its language rules across several articles and two annexes. Each row below can be answered by a different authority.

Document or information	Legal basis in MDR 2017/745	Who determines the language
Label and instructions for use	Article 10(11); Annex I Chapter III, Section 23	The Member State in which the device is made available to the user or patient
Implant card and patient information	Article 18(1)	The Member State concerned
EU declaration of conformity	Article 19(1)	The Member State(s) in which the device is made available
Field safety notice	Article 89(8)	Where the corrective action is taken
Information requested by a competent authority	Articles 10(14), 11(3)	The Member State concerned
Labels and IFU held in the technical documentation	Annex II, Section 2	The languages accepted where the device is to be sold
Documents submitted for conformity assessment	Article 52(12)	Where the notified body is established
Documents for designation of a notified body	Article 41	The Member State concerned
Electronic instructions for use on the website	Regulation (EU) 2021/2226, Article 5(11)	The Member State in which the device is made available to the user or patient

Annex II, Section 2 is easy to overlook: the technical documentation must hold the labels and instructions for use in the languages accepted in every Member State where the device is envisaged to be sold, so the file grows with each new market.

There is no single EU language for devices

Because the MDR delegates the choice, the medical device label language requirements that bind you are found in national law. The Commission does publish an overview: DG SANTE maintains a table titled "MDR - Language requirements for manufacturers", revised in August 2025, with an equivalent table for the IVDR. It was compiled after a Medical Device Coordination Group consultation and carries an explicit caveat: "The Commission services do not take responsibility for the correctness of the information in the table. In any case, the provisions of the MDR and the provisions of the Member States implementing the MDR in respect of language requirements take precedence over the information in this table."

Two points from that table matter more than any single row. First, "Member States are not obliged to determine a specific language." Second, the Commission records an encouragement rather than a rule: "Having regard to the costs related to providing information in various languages, Member States are encouraged to consider whether information to be provided by the manufacturer could be accepted in another language than their national language (e.g. in English) if the safe use of the device is not compromised, especially regarding devices for professional use."

That lay-user versus professional-user split governs commercial planning. Germany's MPDG allows German or English for professional users while requiring German for patients and lay users, and the Dutch Regeling medische hulpmiddelen is built the same way. Others do not split: Spain requires Spanish and Sweden requires Swedish for both. None of that should be taken from memory or assumed stable — check the current national instrument, or the Commission table and the legislation it hyperlinks, before artwork is signed off.

eIFU under Regulation (EU) 2021/2226: what it does and does not allow

Commission Implementing Regulation (EU) 2021/2226 replaced Regulation (EU) No 207/2012 and is the only route to supplying instructions for use electronically instead of on paper. It is narrower than most manufacturers hope. Article 3(1) covers implantable and active implantable devices, fixed installed devices, their accessories, and devices with a built-in system visually displaying the instructions, plus software under Article 3(3). Article 3(2) adds two cumulative conditions: "the devices and accessories are intended for exclusive use by professional users" and "the use by other persons is not reasonably foreseeable."

Going electronic relaxes the label language requirement not at all. Article 5(11) provides that "the instructions for use shall be available on their website in an official language of the Union determined by the Member State in which the device is made available to the user or patient". The translations still have to exist; they live on a website instead of in the box. Article 5(3) also requires a system for delivering paper instructions free of charge "at the latest within 7 calendar days of receiving a request from the user or at the time of delivery of the device if so requested at the time of order", which means print-ready translated files, not just a PDF viewer.

For implantables, Article 6(4) closes the loophole: "Where, for devices and accessories referred to in Article 3(1), point (a), a part of the instructions for use is intended to be provided to the patient, that part shall not be provided in electronic form." The patient-facing part stays on paper, in the national language.

Selling into several Member States at once

Treat medical device label language requirements as a market-entry decision, not a late artwork task. Before packaging is finalised, fix the list of Member States, establish what each requires for label, instructions for use, declaration of conformity and, where relevant, implant card, and decide whether the device is lay-user or professional-user there — the answer often changes the language.

From there the constraints are physical and procedural. Multilingual text on small primary packaging runs out of space fast, which is why symbols under EN ISO 15223-1 are worth exhausting first, and each added language brings another translation-control record and another version to keep synchronised whenever the instructions change. One further trap: a distributor or importer who translates your instructions for use is performing an activity regulated by Article 16, with quality management system and notification consequences for that operator.

Where Medex fits

Medex acts as EU authorised representative under MDR Article 11 with EUDAMED SRN TR-AR-000057550, and that role includes holding your label, instructions for use and declaration of conformity in the language versions a competent authority may request under Article 11(3). We can map the language questions your target Member States raise and keep those versions on file for inspection; we do not perform notified-body conformity assessment, we do not write technical documentation, and we do not source translators or local distributors. Class-based annual pricing is published.