EU Commission and Member States have created country language tables

The EU Commission and Member States have created country language tables in order to provide an overview which language requirements are required by each Member State for following items:

– Labelling & Instruction for Use (patient, lay user or professional user)
– Implant card
– Declaration of conformity
– Field safety notice
– Graphical user interface, e.g. (mobile) apps (patient, lay user or professional user)

The tables were provided for both, MDR and IVDR. See here for more info on MDR EU 2017/745 and IVDR EU 2017/746.