MDR and IVDR Language Requirements Update

The European Commission, in collaboration with Member States, has introduced tables under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). These tables are designed to assist manufacturers, especially small and medium-sized enterprises, in understanding the language requirements for the information and instructions accompanying medical devices in specific EU Member States.

Click here to view the MDR language requirements for manufacturers.

Click here to view the IVDR language requirements for manufacturers.

Key Points:

• • MDR and IVDR – language requirements: The newly introduced tables offer a comprehensive overview of language requirements for each Member State. This information is particularly beneficial for manufacturers seeking clarity on linguistic expectations for their medical devices.
    • The language requirements impact the following documentation:
      • Label(s) and IFU(s), depending on whether it is for professional use and/or patient/lay users;
      • Implant card(s);
      • Declaration of conformity;
      • Field safety notice;
      • Documents for conformity assessment; and
      • (Graphic) user interface (e.g. Apps), depending on whether it is for professional use and/or patient/lay users.
  • Summary of Safety and Performance of a device (SSP) as per Art. 29 IVDR: please see the MDCG-2022-9,  that recommends the SSCP to “be written in a way that is clear to the intended user and, if relevant, to the patient (see MDR, Annex II (2), Article 10 (11)), the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold”.

Learn more about the new MDR and IVDR language requirements with MedEnvoy 

We believe that these updates will be instrumental in ensuring compliance with language requirements across different Member States. We encourage you to review the MDR and IVDR tables provided by the Commission to gain insights into the specific language requirements applicable to your medical devices and update your SOP on translations and labeling accordingly.

If you have any questions or need more clarification on these updates, please contact us. For more information about our regulatory experts click here.

Related articles:

• • Annex II Under the MDR: What is a Technical File?
  • Medical Device Risk Management: Hazards and Controls