New IVDR/MDR overview of language requirements for manufacturers of medical devices

What is the effect hereof on the use of eIFU?

For manufacturers who are not using eIFU yet:

Are you a manufacturer facing the challenge of complying with the new language requirements for Instructions for Use (IFUs) and labels? The impact of these requirements might not seem directly related to electronic Instructions for Use (eIFU) at first glance, but the way you handle document content can significantly affect your manufacturing and labeling processes.

Consider this scenario: a country mandates the addition of a new language to your IFUs. For manufacturers still relying on paper-based IFUs, this means a complex and costly process. Translating the IFU, pushing through formal revision, printing updated copies, and replacing outdated IFUs in product packages can consume valuable time and resources. Imagine the effort required to update your entire warehouse stock!

Now, imagine the same scenario with eIFU. With electronic Instructions for Use, the process is streamlined. A simple translation and a single upload to your website grant your customers automatic and immediate access to the updated IFU. No need to deal with printing, packaging updates, or warehouse overhauls.

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, simplifying compliance and saving you time and resources.

Reach out to us for more information about eIFU or to schedule a demo of IFUcare.

For manufacturers who are using eIFU:

As a manufacturer, staying abreast of regulatory changes is crucial to ensure compliance and efficiency. The recent language requirements issued by the European Commission are no exception. That is why we highly recommend to review the updated language requirements and evaluate how they might impact your online documentation.