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.

Under the “old” MDD, it was already a requirement to provide patients with an implant card for implantable medical devices. However, this was not a clear and documented process, leading to varying national requirements across different EU member states. With MDR Art. 18, “Implant card and information to be supplied to the patient with an implanted device,” this process will become more standardized throughout the EU. This article stipulates that a significant amount of information should be provided to the patient via an implant card and “…by any means that allow rapid access to that information and shall be stated in the language(s) determined by the concerned Member State. The information shall be written in a way that is readily understood by a lay person and shall be updated where appropriate.”

This additional information could be provided through a sticker system on pre-existing cards or by printing the information directly on the card. Furthermore, it is recommended that the leaflet containing the relevant information be provided along with the Implant Card and the implantable device.

It is important to note that regulatory requirements evolve, and there may have been further developments or updates to the MDR or other related regulations. Therefore, it’s advisable to consult the latest regulatory updates and seek professional translation support.