On January 17th, 2024, the European Commission published an overview of the language requirements for manufacturers of medical devices, with specific tables for MDR and IVDR.
What is the effect on eIFU?
For manufacturers not using eIFU yet: When a country mandates adding a new language, paper-based manufacturers face a complex process: translating, printing, and replacing outdated IFUs. With eIFU, a simple translation and upload grants automatic access to the updated IFU. No printing, packaging updates, or warehouse overhauls needed.
For manufacturers using eIFU: Staying abreast of regulatory changes is crucial. We recommend reviewing the updated language requirements and evaluating their impact on your online documentation.
At IFUcare, we understand the challenges manufacturers face in meeting regulatory requirements while optimizing efficiency. Our eIFU solution offers a seamless transition to electronic Instructions for Use.
