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EU Commission and Member States have created country language tables
The EU Commission and Member States have published country language tables for MDR and IVDR. A short summary of what the tables cover, from labelling to graphical user interfaces.
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.
KEY TAKEAWAY
Country Language Tables Published for MDR and IVDR
The EU Commission and Member States have published country language tables summarising language requirements across the EU for both MDR and IVDR. The tables cover labelling and instructions for use (for patient, lay user, or professional user), implant cards, declarations of conformity, field safety notices, and graphical user interfaces such as mobile applications.
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