Regulatory Translations for Medical Devices: Essential Guide to EU MDR Compliance

Accurate translations of medical device materials – instructions for use (IFUs), labels, and other supporting documents – are vital for patient and user safety. The EU’s Medical Device Regulation (EU MDR) requires that all devices marketed in Europe include precise, compliant translations to prevent errors and ensure proper, safe use. By enforcing stringent linguistic and technical standards, the MDR ensures that no nuance is lost in translation.

In this guide, we’ll explore the regulatory framework that governs medical device translations under the EU MDR and offer practical insights to help manufacturers achieve (and maintain) full compliance when marketing medical devices.

What Is the EU Medical Device Regulation (MDR)?

The EU Medical Device Regulation (MDR) (EU) 2017/745 is a directly applicable legal framework, enacted on May 26, 2021. It governs the design, manufacture, clinical evaluation, labeling (including translations), conformity assessment, and post‑market surveillance of all medical devices sold in the European Union.

The EU MDR replaces the previous Medical Device Directive (MDD), introducing the following to improve transparency and patient protection:

• Stricter safety and performance requirements
• A unique device identification (UDI) system
• Enhanced clinical evidence standards
• A centralized database (EUDAMED)

Understanding EU MDR Language Requirements

The EU MDR establishes a directly applicable framework for ensuring that any medical device placed on the EU market is safe, effective, and accompanied by the information that users and patients need. The two key language-related provisions are:

• EU Regulation 2017/745 (MDR) Article 10, Paragraph 11
  “Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I (‘Labels and Instructions for Use’) 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.”
• EU Regulation 2021/2226 (Instructions for Use for Medical Devices) Article 5, Paragraph 11
  “(…) 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.”

As highlighted in our recent guide, medical devices in the EU must meet three distinct tiers of language requirements under the MDR:

• EU Level: General language rules set out by the EU MDR 2017/745
• National Level: Specific language rules that are determined by the EU’s Member States
• Device Level: Language rules particular to the device

What Are the Official Languages of Each EU Member State?

Here is a list of each EU Member State, along with their official languages:

• Austria - German
• Belgium - Dutch, French, German
• Bulgaria - Bulgarian
• Croatia - Croatian
• Cyprus - Greek, Turkish
• Czechia - Czech
• Denmark - Danish
• Estonia - Estonian
• Finland - Finnish, Swedish
• France - French
• Germany - German
• Greece - Greek
• Hungary - Hungarian
• Ireland - Irish, English
• Italy - Italian
• Latvia - Latvian
• Lithuania - Lithuanian
• Luxembourg - Luxembourgish, French, German
• Malta - Maltese, English
• Netherlands - Dutch
• Poland - Polish
• Portugal - Portuguese
• Romania - Romanian
• Slovakia - Slovak
• Slovenia - Slovenian
• Spain - Spanish
• Sweden - Swedish

What Are the Exceptions to the EU MDR Language Requirements?

Some Member States allow you to translate only selected parts of your documentation. For example, Germany’s updated Medical Device Law mandates in Paragraph 8 that the EU Declaration of Conformity be in German or English. All other information may stay in English (or another language familiar to professional users), provided any safety‑related content is translated into German (or the local language of the intended user).

Here are the key examples of where only certain parts of a medical device must be translated:

Professional‑User Exemptions (English‑Only for Non‑Lay Devices)

Austria, Belgium, Croatia, Cyprus, Estonia*, Iceland, Liechtenstein, Luxembourg, Netherlands, Poland, Romania*, and Switzerland.

*In Estonia and Romania, professional users must first consent to receiving English‑only materials.

Safety‑Critical Subset Only

Germany and Finland permit English for all documentation, except that essential safety‑related information must be translated into the local official language.

GUI‑Specific Concessions for Lay‑User Devices

Hungary, Latvia, and Poland allow the GUI to remain in English, provided that any concepts not presented on‑screen are fully explained in the national language in the IFU or accompanying materials, and that this does not pose a risk to the user of the device.

How to Interpret EU MDR Language Requirements for the GUI

The EU MDR does not explicitly address a device’s Graphical User Interface (GUI) as a separate element subject to translation requirements. Instead, it simply states that “the device is accompanied by the information set out in Section  23 of Annex I”. Section 23 defines “information needed to identify the device and its manufacturer, and any safety and performance information relevant to the user” without distinguishing where that information appears (on the device surface, in packaging, in IFUs, or on‑screen).

What Does This Mean for Medical Device Manufacturers?

In practice, this means any safety or performance text presented via the GUI falls under the same language obligations as the labels or instructions. The industry interpretation – endorsed by MedTech Europe in a June 2022 position paper – is that GUI text needs only to be translated if it conveys information covered by Section 23 (e.g., warnings, operating parameters), and that a formal risk analysis should determine whether on‑screen text affects safe use.

Only 16 EU Member States* have issued specific guidance on GUI language, and some permit English‑only interfaces for lay users – provided the companion IFU explains any key concepts in the local language. Ultimately, manufacturers must treat on‑screen safety and performance messages as they would any other label or IFU content and verify, per each Member State’s rules, which official language(s) must be supported.

*Under the EU MDR, Iceland, Liechtenstein, Norway, and Türkiye also include information about GUI translations. However, they are classified under the European Economic Area (EEA), or Customs Union (CU) for Türkiye, not as an EU Member State.

5 Common Challenges of Ensuring Translation Compliance

Here are five common challenges in achieving EU MDR-compliant translations, and how professional life sciences translation provider can help:

1. Maintaining Balance Between Accuracy & Clarity

Translating highly-technical terminology without sacrificing readability for end users is a difficult task. Professional translators with medical device expertise ensure that safety‑critical terms are precise, while end‑user instructions remain clear.

2. Translation & Localization Complexity

Beyond simple translation, content must be adapted to the cultural, regulatory, and linguistic nuances of each EU Member State, some of which are more complex than others. Specialists manage language variants, date and number formats, and units of measure, avoiding potentially costly misinterpretations.

3. Extensive Documentation Requirements

The MDR demands multiple documents (IFUs, labels, clinical evaluation reports, risk analyses, technical files, etc.) in multiple languages. A dedicated translation service streamlines project workflows, version control, and terminology consistency across all materials.

4. Resource & Expertise Gaps

In‑house teams often lack the linguistic skills and the regulatory knowledge needed to produce compliant translations. Outsourcing to vetted language service providers fills those gaps, bringing established QA processes and greater regulatory awareness.

5. Software & Legacy Device Reclassification

Devices with on‑screen interfaces or older products being reclassified require updates to software and legacy documentation. Professional medical translators facilitate the integration and translation of GUI, ensuring nothing is overlooked.

Contact Us for Accurate, Compliant Medical Device Translations

At Conversis, we provide compliant translations across every part of the medical device lifecycle, including the earliest development steps, clinical investigations, regulatory submissions, and post-market surveillance. This ensures that your device (and all supporting documents) is safely understood by the intended market, avoiding the risk of any miscommunication that could harm the user or patients.

We’ve been working alongside medical device companies since 2003, so we’re experienced in handling any translation needs your team may have. For more information, please get in touch with our ISO-certified team today.