Medical device CE marking

Revision 1 of MDR and IVDR language requirements for manufacturers published


The Commission and Member States have created a revision 1 of the 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.

The documents can be downloaded in our library: MDR / IVDR

Source: European Commission