MDR Language Requirements by EU Member State

This article presents the language requirements for medical devices under the EU Medical Device Regulation (MDR). This comprehensive reference covers 30 countries including all 27 EU member states plus Iceland, Liechtenstein, Norway, and Turkey.

The requirements distinguish between Patient/Lay Users (individuals without formal medical education) and Professional Users (healthcare professionals), with different language obligations for each group. Many countries allow English as an alternative language for professional users, providing greater flexibility for healthcare professionals who typically have English proficiency.

Patient/lay user requirements are generally more restrictive, requiring translation into the official national language(s) to ensure patient safety and comprehension. This table specifically covers Instructions for Use (IFUs) and Labels only. Additional documents like implant cards, GUIs, declarations of conformity, and field safety notices have separate requirements detailed in other guidance documents.

This table serves as a crucial reference for medical device manufacturers to determine their translation obligations when marketing devices across European markets, ensuring compliance with both patient safety requirements and regulatory standards.

Table: Language Requirements for IFUs and Labels

Three Language-Level Requirements for MDR Compliance

Note: The information presented in this table is intended for reference purposes. To ensure compliance, seek guidance from the authority of the relevant EU member state. Additionally, the provided information may be subject to updates, and all particulars were accurate to the best of our knowledge at the time of publication.

Reference: 

1. https://health.ec.europa.eu/document/download/aa9760e3-c864-4173-8b16-d790dac66d74_en?filename=md_sector_lang-req-table-mdr.pdf