Effects of Official Regulations on Medical Technology Documentation
Current Guidelines and Regulations for Medical Technology
In late 2012, the EU Commission and the European Parliament proposed a new Medical Devices Regulation (MDR) that is currently in thefinal approval process. This new text explicitly requires multilingual,
comprehensible documentation, making it necessary for many medical technology companies to restructure their previous editorial processes and consider the subject of translation and translation management. This white paper summarizes the changes and shows how businesses can tune their processes to the future regulations.