In which languages must an IFU be provided under the MDR?

According to Article 10(11) of MDR 2017/745, the information that the manufacturer must supply pursuant to Annex I Section 23 shall be provided in the official Union language(s) determined by the Member State concerned. In practice, this means you must cover the official language(s) of every EU Member State where you place your product on the market.

What happens if I fail to meet the MDR language requirements?

Non-compliance with language requirements can result in your Notified Body rejecting or imposing conditions on the conformity assessment. Market surveillance authorities may also prohibit the distribution of your product in the affected Member State. In the worst case, fines and recall measures may follow.

Can I provide an IFU only electronically instead of in paper form?

The MDR permits electronic provision of instructions for use (eIFU) under certain conditions, governed by Regulation (EU) 207/2012. However, this applies only to certain product classes and requires that the user is informed and can request a paper version at any time. The language requirements apply equally to electronic IFUs.

Regulierung

MDR Language Requirements: What You Need to Know

EU MDR Article 10(11) and Its Consequences for Your Product Documentation

10 min read

Overview: MDR Language Requirements

The EU Medical Device Regulation (MDR 2017/745) has significantly tightened the requirements for medical device manufacturers — including language obligations. Article 10(11) stipulates that all information pursuant to Annex I Section 23 must be provided in the official language of the respective Member State. For manufacturers distributing their products across the EU, this means a substantial translation workload.

This article applies not only to the instructions for use themselves but to all information supplied with the product: labels, packaging inscriptions, implant cards, and all safety-relevant notices. The language requirements also apply regardless of whether information is provided in paper or electronic form.

Which Languages Are Mandatory?

The MDR itself does not define a fixed language list. Instead, it defers to the determination of individual Member States. In practice, this means:

Each EU Member State can determine in which official language product information must be provided. Most Member States require their respective national language. Belgium, for example, requires three languages (Dutch, French, German), while Finland demands two (Finnish, Swedish).

For a manufacturer distributing products in all 27 EU Member States, this creates the need to translate the IFU into up to 24 different languages. Additional languages may be required for further markets such as Switzerland, Norway, Iceland, and Liechtenstein under the EEA Agreement.

Country List and Language Overview

A complete country list with respective language requirements should be part of your regulatory dossier. manualworks provides you with an always up-to-date overview of required languages per target market, ensuring you never miss a language during project planning.

Requirements for Translation Quality

The MDR requires not just that translations exist — they must also be accurate and comprehensible. Annex I Chapter III Section 23.1 stipulates that information must be understandable to the intended user, taking into account the training, knowledge, and experience of the user.

In concrete terms, this means a literal translation is insufficient. The translation must be linguistically and technically prepared so that a user in the target country can use the product safely and as intended. This requires translators with medical device expertise and ideally knowledge of the target user group.

Special Requirements for Certain Product Classes

Additional requirements apply to implants: the implant card pursuant to Article 18 must also be available in the language of the Member State. For in vitro diagnostics (IVDR 2017/746), parallel language requirements exist, governed by Article 10(11) of the IVDR.

Documentation Obligations in the QMS

The MDR language requirements have direct implications for your quality management system under ISO 13485. You must be able to demonstrate that your translation process is controlled, validated, and documented. This includes:

The qualifications of translators and reviewers must be documented. The translation process itself must be described as a controlled process in your QMS. Changes to the source IFU must be traceably transferred to all target languages, and the release of each language version must be documented.

Notified Bodies are increasingly scrutinizing translation processes as part of conformity assessment. Incomplete documentation can lead to conditions being imposed or even certification being refused.

Practical Recommendations for Implementation

Begin with a language needs analysis: In which markets are your products approved or intended to be approved? Which languages does this require? Plan the translation effort early in your product development — not just before market launch.

Rely on centralized translation management that consolidates all languages, versions, and approvals in one place. manualworks was designed for exactly this use case: it integrates terminology management, translation memory, and version control into an end-to-end workflow with MDR-compliant documentation.

Establish a review process that ensures both linguistic quality and regulatory correctness. Ideally, a native-speaking subject matter expert reviews linguistic quality, while a Regulatory Affairs Specialist validates regulatory compliance.

Conclusion

MDR language requirements are not an optional add-on but a fundamental regulatory obligation. Those who underestimate them risk approval delays, objections from Notified Bodies, and in the worst case, exclusion from key markets. A structured, tool-supported translation process is the key to efficient and compliant implementation.