New guidance document on MDR/IVDR Language requirements

New guidance document on MDR/IVDR Language requirements

In January 2024, the Commission issued a guidance document on MDR/IVDR Language requirements. It provides an overview of language requirements for medical device manufacturers covered by Regulation (EU) 2017/745 (MDR) and in vitro diagnostic medical devices covered by Regulation (EU) 2017/746 (IVDR) for the information and instructions that accompany a device in a specific country. The document was updated in March 2024.

For more, see the Commission’s webpage on guidance.