National language requirements in the EU for MDR & IVDR devices

The European Commission has released a table on the existing language requirements for manufacturers under MDR and IVDR, compiling all national language requirements required for devices in EU Member States. As such, the European Commission addresses one of the main challenges for medical devices and IVD manufacturers placing devices in the EU market. Therefore, it provides indications of the language requirements in the following areas:

  • Label/IFU
    • MDR: for lay users and professional users;
    • IVDR: for information accompanying the device and devices for self-testing or near-patient testing;
  • Implant card information;
  • Declaration of Conformity information;
  • Field Safety Notice (FSN);
  • Documents for conformity assessment;
  • User interface information.

Furthermore, the documents indicate the relevant national legislation for each country. The MDR and IVDR tables can be consulted here for MDR and here for IVDR, while you can also consult our national analysis on Member States legislation covering all relevant national requirements in our RA Map

You can find this and other relevant information in our European Commission MDR and IVDR sections!

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