Overview of language requirements for manufacturers of medical devices

The Commission and Member States have created MDR and IVDR tables.

These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requirements for each Member State.

Graphic User Interface (GUI)

The last column of the tables includes the language requirements about the graphic user interface (GUI) (e.g., apps). There is no specific article foreseen in MDR/IVDR, but some countries have their own national legislation and rules about GUIs.

Example of a GUI

External readout devices can be used to make screenshots and provide examples of a GUI, e.g., saving screenshots from a device for brain pressure measurement.

The saving function is included on the GUI's "Save" button.

All the information about the "Save" function is already included in the language of the country where the device is used and does not need to be translated. An image (an icon for saving) could also be used instead of the button, whose function would then be explained in the instructions for use (IFU).