The EU Commission has updated the MDR Language Requirements Table. To offer some background to this update, the document, initially released in January of 2024, was published to aid manufacturers navigate the language requirements of different member states. The table is very well organised and is segmented per EU Member states making reference to the relevant legal provision where the requirements are stated. In addition, it details the language requirements for the following documents l accompanying the device:
- Label and IFU for Lay User
- Label and IFU for Professional User
- Implant Card
- Declaration of Conformity
- Field Safety Notice
- Documents for Conformity assessment
- Graphic user interface for lay User
- Graphic user interface for Professional User
The updated language requirements table can be accessed using the following link
