MDR: key features to comply with language and translation requirements 6/6
After a one year postponement, in exactly 6 months, the EU MDR will become fully applicable in the European Union. In the past year we have regularly published articles, that we hope will help you understanding the challenges the MDR represents for medical device manufacturers and distributors. As a conclusion today, we would like to share a quick highlight of the 3 key novelties that will have an impact on the way the linguistic part of the EU MDR compliance process are approached.
Increased transparency and traceability with information accessible to general public via EUNAMED among which a unique UDI.
Life-cycle monitoring with Post-market surveillance which implies regular evaluation and updates of documentation. PMS under closer watch by NB with obligation to create a PMS report or a PSUR depending on the classification of the device. All updates to technical documentation will have to be uploaded to EUNAMED.
Adequate access to information: translations of technical documentation compulsory into each official language of the member state in which the device is made available. Writing in a clear, understandable way to avoid ambiguity and to be accessible to laypersons. Rapid access for the public to information (detailed labels, identification and IFU) via EUNAMED and on the manufacturer’s website.
We will add a special note on clarity and consistency. When it comes to drafting your technical documents, make sure you use a clear and adapted language, consistent terminology all throughout the different documents in order to provide comprehensible information to the intended user or patient. Not only you will have to focus for each document on the targeted audience (healthcare professionals and/or patients) and its level of understanding, you will also have to erase any chance of misunderstanding or confusion by using non consistent terminology. Let’s take the example of the first section of your technical file, “device description” in which you present a broad understanding of your device. This information will also be partly found in the IFU and in labels and packaging but also in the following General Safety and Performance Requirements (GSPR) section. It is important, in order to avoid any doubts on the reader’s behalf, that the wording you use is similar all throughout the different parts of your documentation. This consistency will have to be mirrored in the translated versions and in any further update.
The best way to tackle this issue would be setting up a specific file management system that takes into account the life-cycle of your documentation with its corresponding translations (that could go up to 24 languages depending on your market’s scope). At Baguette, we also organize pre-translation sessions with the translators in order to put together an agreed-upon terminology that will be used throughout the project(s) and that can be updated consistently when necessary.
Don’t hesitate to contact us if you have questions regarding the processes we have put in place to accompany manufacturers and distributors in implementing the MDR language requirements.