Navigating Language Requirements for Medical Device Manufacturers

The European Commission, alongside Member States, has developed tables outlining the language requirements for medical device and in vitro diagnostic device manufacturers. These resources are designed to clarify the linguistic demands for device information and instructions within different countries, aiding especially the small and medium-sized enterprises. Additionally, guidelines regarding the graphic user interface (GUI) for apps are included, considering national legislations and rules. This initiative helps ensure compliance and facilitates market access across EU Member States.

🔗 Original: https://health.ec.europa.eu/publications/overview-language-requirements-manufacturers-medical-devices_en