eIFU under MDR: A Practical Guide

Implementing electronic Instructions for Use (eIFU) under MDR is more than a documentation choice — it is a compliance, safety, and usability decision. Language rules differ across EU Member States, which means the same eIFU cannot be reused unchanged across Europe without prior verification. Writing quality directly affects how instructions are understood and applied in clinical settings, and for some devices, IFU content may qualify as a Risk Control Measure.

Meanwhile, over 88% of healthcare professionals prefer eIFU when it is available, and the operational benefits are measurable: real-time updates, keyword search, reduced waste, and lower logistics costs.

This guide brings together three practical cheat sheets to help medical device manufacturers navigate language compliance country by country, write clearer and safer instructions, and build the business case for going digital.

Download the guide to get started.