Understanding the Impacts the new MDR will have on Translations
In May 2017, two new European Regulations concerning medical devices and in vitro medical devices were implemented. The existing framework came under pressure to modernize and to better address risk management in order to help ensure the ongoing safety of medical devices sold in the European Union. Whether you are headquartered in one of the European Union countries or simply exporting to one of them, your business must meet the requirements demanded by these regulations.
What influence does the MDR have on your Translation & Localization Program?
Due to the new regulations the need for translations might increase. The legislation will not only affect technical documentation but also labels on medical devices and packaging: as an example, new UDI requirements will impact labeling layout, making it crucial that new designs take localized text expansion into account. Reclassifications to your products might cause changes to your technical documentation, which will need to be translated to the languages of your target markets. Furthermore, applications for clinical investigation and analyses of serious incidents may also require translation.
Thus, these new regulations require close partnership with localization suppliers to ensure compliance in your translations. It is important to start talking to your language solutions provider to prepare a cost and time-effective solution across all affected content for all your targeted markets in the European Union and their corresponding languages.
Find out more about the new MDR!
Argos Multilingual recently published a whitepaper about the new regulations: “The 2017 EU Medical Device Regulations Under the Microscope, and What Do They Mean For Translations”– highlighting how and what the new regulations will exactly look like:
• The scope of the regulation
• Why the changes happened
• What happens when – dates for compliance
• How to prepare for these upcoming changes
• How it will impact your multilingual content and Quality Management systems
Download the FREE Whitepaper and be prepared for the new MDR!