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

On January 17th, 2024, the European Commission EU Health and Food Safety (DG Sante) published an overview of the language requirements for manufacturers of medical devices. The Commission and Member States have created specific tables for MDR and IVDR.

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The tables provide an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers.

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 Translating the IFU, pushing through formal revision, printing updated copies, and replacing outdated IFUs in product packages can consume valuable time and resources.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.

Software requirements for a compliant eIFU website development

This document contains an overview of software requirements for an eIFU website and how the Software Development Life Cycle (SDLC) can serve as a guide to create a compliant system.


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