The Unique Language Challenges of IVDs and the EU IVDR

When the EU MDR went into application in 2021, Lionbridge published a white paper on language requirements under this new regulatory reform. With the EU IVDR Date of Application, 26 May 2022, approaching, we continue to examine the impact of regulatory language requirements on life sciences companies. 

Under the MDR, language has become an increasingly important and challenging activity in the European market. We continue to recommend manufacturers be aware of three important language levels in the EU: a Union level, a national level, and a device level. In this new white paper, we turn our attention to in vitro diagnostics and some of the unique language challenges of this specific type of medical devices.