In the end of april, INFARMED published a new guidance document regarding the requirements for language regarding the graphic user interface (GUI) for medical devices used by professionalsThe document clarifies expectations for:
- Language options for professional-use medical devices
- Minimum content for instructions for use of medical devices with english GUIs
- Practical requirements for manufacturers placing medical devicesfor professional useon the Portuguese market with english GUIs
📍 The update aims to support better compliance and harmonisation with EU regulatory frameworks and improve patient and user safety.
📄 The full documentation is available here.
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