Introduction

The European Union (EU) maintains strict requirements to ensure that medical devices and in vitro diagnostic devices are safe and effective for users across all Member States. One key area of compliance under the Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746 is the language in which product information is provided. Manufacturers, importers, and distributors must ensure that all documentation is clear, accessible, and provided in the official language(s) of the country where the device is marketed or used.

What About Translations?

Translations must be accurate and validated. Many manufacturers work with professional, medical-specific translators to reduce the risk of misinterpretation. Poor translations can lead to non-compliance, user confusion, and even product recalls.

Why This Matters (Risks Of Non‑compliance)

• Non‑compliance with language requirements may lead to a device being considered non‑conforming under MDR/IVDR which can trigger recalls, market withdrawals or restrictions.

• Poorly translated or incomprehensible documentation increases risk of misuse, adverse events, which raises regulatory and liability risk.

• Language requirement failures may complicate post‑market surveillance (users/patients may not understand instructions, may not report incidents properly) and may impact vigilance obligations.

Who Is Responsible For Ensuring Language Compliance?

Under MDR and IVDR

• Manufacturers are primarily responsible for ensuring that all product information complies with language requirements.

• Importers and Distributors must verify that the device they place on the market complies with these requirements. This includes checking that documentation is available in the correct language.

• Authorized Representatives (ARs) must ensure that the manufacturer fulfills these obligations, particularly for non-EU manufacturers.

Legal References And Obligations In MDR And IVDR

Under MDR

• The label and packaging of the device must have the particulars required, and instructions for use (IFUs) must be provided. (See MDR Annex I, Chapter III – Section 23)

• The information must be “readily understood by the intended user” (which implies language usability) and must be in a format appropriate to the intended user, which includes considering language, training, and technical knowledge. 

• Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The following table gives an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers.

• Member States are not obliged to determine a specific language. 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

• Member States have the right to determine which official Union language(s) apply for their territory. The Manufacturers must comply with that national requirement. (See European Commission table “MDR – Language requirements for manufacturers”.) 

• Other language requirements: For the Summary of Safety and Clinical Performance of a device (SSCP), Art. 32 MDR, please see the MDCG-2019-9 Rev.1 Guidance Document, that recommends the SSCP to “be written in a way that is clear to the intended user and, if relevant, to the patient (see MDR, Annex II (2), Article 10 (11)), the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold”(p. 6)

Under IVDR

• The information set out in Section 20 of Annex I covers labelling, instructions for use, any symbols, user interface etc., and must satisfy language requirements.

• As with MDR, the Member State may determine which official language(s) apply; if the information is provided in another language (for example English) only if the Member State allows and safe use is not compromised. The Commission’s table for IVDR shows how language rules vary by Member State.

• Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The following table gives an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers. (See European Commission table “IVDR – Language requirements for manufacturers”.) 

• Member States are not obliged to determine a specific language. 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. 

Practical Implications And Country‑specific Variations

• Although the Regulation sets the general obligation, the actual language(s) required depend on the Member State where the device is being made available. The tables published by the European Commission show which countries require their national language(s), and whether they allow English (especially for professional‑use devices) as an alternative.

• Some Member States may accept English for professional‐use devices if safe use is not compromised; others insist on the national official language(s) for all devices including those for professionals.

• For manufacturers distributing in multiple EU markets (including your markets in Austria, Germany, Netherlands, Belgium, France, Greece, Italy, etc.), you must map each country’s language requirement and ensure for each device/market the correct language version of the label/IFU etc.

• If your device is intended for lay persons (patients) rather than professional users, you will typically be required to provide the documentation in the national language of the user’s Member State – not just in English.

• A key grey area is e‑IFU (electronic instructions for use) and whether “on‑device”, “on‑packaging” or “online” documentation can substitute printed IFU; the language obligation remains the same: the user must be able to access the information in the language required by the Member State.

Key Compliance Steps For Manufacturers/Distributors

• Early in your market‑access planning, create a table of all Member States where you intend to place the device and list the official language(s) required for label/IFU/documentation for each. Use the Commission's tables (for MDR & IVDR) as reference.

• Ensure that your label and IFU content development process includes translation into each required language and that it is reviewed/validated (ideally by a person familiar with the medical/technical context and the target language).

• Determine whether your device is for professional users or lay/patient users; many Member States allow more flexibility (e.g., English) for professional devices, but not always for patient use devices.

• Update your QMS and change‑control process: If you change your IFU content, label, packaging, you must trigger translation updates and verify for each language version.

• Ensure that instructions, user interfaces, packaging etc. consider the language abilities of the intended user: the text must be clearly understandable to the user in that‐language. (MDR Annex I, Chapter III)

• Keep records of which language versions you have provided to which markets, and evidence of translation/validation, as this may be requested by Notified Bodies or Competent Authorities during audits.

Conclusion

Language compliance under MDR and IVDR is a critical part of market access in the European Union. Ignoring or underestimating this requirement can lead to regulatory delays, fines, or even product withdrawal. By taking a proactive approach understanding the legal obligations, engaging reliable translation services, and coordinating with your distributors or AR you can ensure smooth and compliant operations across the EU.

How Morulaa Can Help

Morulaa helps medical device manufacturers meet EU language requirements by mapping country-specific rules, coordinating certified translations, validating IFU and label content, and acting as your EU Authorized Representative. We ensure full MDR and IVDR compliance across all Member States.