The European Commission, in collaboration with Member States, has recently released two essential documents outlining language requirements under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Medical Device Regulation).

These comprehensive tables have been designed as indispensable tools, particularly beneficial for small and medium-sized medical device manufacturers. They play a crucial role in facilitating a nuanced comprehension of language requirements, offering clear guidance on information and instructions accompanying devices in specific countries. This initiative aims to streamline communication and enhance compliance within diverse linguistic landscapes, fostering a more accessible regulatory environment for medical device manufacturers.

MDR – language requirements for manufacturers

IVDR – language requirements for manufacturers

At MDSS we specialize in assisting medical device manufacturers with seamless national registrations, ensuring compliance with the intricate language regulations outlined in the MDR and IVDR and with the additional national requirements specific of some EU countries.

Reach out to us if you have any questions or require assistance.