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On August 29, 2025, the European Commission published Revision 3 of the document “MDR – Language Requirements for manufacturers.” This tool collects and summarizes the language requirements applicable in various member states for medical device manufacturers.

This guide, organized in a table format, clarifies which languages are accepted for each type of documentation, in accordance with the MDR Regulation (EU) 2017/745.

What’s in the Table: Documents Subject to Language Requirements

The general principle of Article 10(11) of the MDR requires manufacturers to provide devices with the necessary information in the official language(s) of the member state where the device is made available to the user or patient.

Specifically, this includes:

  • Device labels
  • Instructions for Use (IFU)
  • Implant card (Art. 18 MDR)
  • Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices
  • Mandatory information for users or patients (e.g., warnings, precautions, conditions of use)
  • Any post-market documentation intended for patients or end-users.

Each country retains the right to establish exceptions or accept additional languages, such as English, in specific circumstances.

The table provides the necessary information for proper compliance, tailored to each device type.

The Updates and Their Practical Impact

Revision 3 confirms the general principle of Article 10(11) of the MDR but introduces significant clarifications, particularly for two member states:

  • Portugal: Translation into Portuguese remains mandatory. However, for documentation intended exclusively for healthcare professionals, the use of English is permitted.
  • Romania: English may be accepted, but only with prior authorization from the competent authorities.

Practical Implications for Manufacturers

The “MDR – Language Requirements for manufacturers” document remains a key tool for navigating the diverse language regulations of the European Union, while confirming the core principle already in place.

This update reinforces a central concept: there is no single, standardized approach to language requirements in Europe. Each market requires a specific and dedicated analysis. For manufacturers, this necessitates a strategic approach, as translations can impact the time and cost of commercialization. Translations must be planned in advance to avoid delays that could block a device from being placed on the market.

The quality of translations is a fundamental aspect of regulatory compliance. A translation error can compromise a device’s safety and effectiveness. Translations must be:

  • Accurate: Correct terminology, consistent with current medical and regulatory standards.
  • Understandable: Clear to the user or patient, avoiding ambiguities that could lead to usage risks.
  • Traceable: Who translated and revised it, and which version was approved.

It is advisable to integrate translations into your Quality Management System (QMS) as a structured and controllable process.

👉Thema consultants can assist you with all necessary aspects of compliance with MDR (EU) 2017/745 and the entire CE certification process.

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