Document paper New medtech regulations

Language Requirements for Texts Displayed On IVD Screens and Software

This position paper considers where the text displayed on the in vitro diagnostic medical devices (IVD) screens and software must be considered as instructions for use. Consequently, where, and how translation is required.

If an IVD system provides information following IVD Regulation (EU) 2017/746, Annex I, Section 20.4 to the users by using a screen (monitor) or in software, these should be considered as instructions for use and should be translated into the appropriate languages.

Legal requirements regarding the language in which IVD information is to be supplied by the manufacturer are set down in Article 10.10 of the IVD Regulation. The requirements for the contents of this information are set down in IVDR Annex I, Section 20.

Posted on 01.06.2022

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