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MDR/IVDR Language requirements
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Overview of language requirements for manufacturers of medical devices
GENERAL PUBLICATIONS
Page contents
Details
Description
Graphic User Interface (GUI)
Example of a GUI
Files
Details
Publication date
17 January 2024 (Last updated on: 29 August 2024)
Author
Directorate-General for Health and Food Safety
Description
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).
Files
18 AUGUST 2025
md_sector_lang-req-table-mdr.pdf
English
(242.68 KB - PDF)
Download
13 SEPTEMBER 2024
md_sector_lang-req-table-ivdr.pdf
English
(241.26 KB - PDF)
Download