Additional Content Subject to Translation under the New MDR
The implementation of the new MDR has introduced several new changes and requirements regarding the labeling and usage instructions for medical devices. These modifications impact the content that requires translation. Specifically, the MDR underscores the importance of providing clear and understandable information to users, encompassing patients, healthcare professionals, and even software UI now recognized as part of product labeling. The classification of software has undergone drastic changes under the EU MDR and IVDR, resulting in virtually no medical device software falling under low-risk categories (unlike the situation under the MDD). The updated language requirements for software are expected to influence manufacturers’ software translation/localization policies, prompting a more rigorous examination of the translated UI.