The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has recently released a key document that provides a comprehensive overview of national language requirements for the information accompanying medical devices.
This crucial resource details the legislative requirements across EU member states, specifying the languages in which various documents, such as labels, instructions for use (IFU), implant cards (when applicable), declarations of conformity, field safety notices, documents for conformity assessment, and (graphic) user interfaces must be provided.
The publication is an invaluable guide for manufacturers, distributors, and all other stakeholders engaged in the marketing of medical devices or in vitro diagnostic medical devices in Europe. It addresses the intricate and often costly process of translation, ensuring compliance with the specific provisions of each member state.
Staying informed and being proactive in adhering to these language requirements is essential to ensure that your products meet both regulatory expectations and the needs of users across the European market.
Have a look at the detailed requirements’ guides here:
MDR Language Requirements for Manufacturers
IVDR Language Requirements for Manufacturers
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