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What is an Instruction for Use (IFU) Document? •Instructions for Use (IFU) is: –Form of prescription drug labeling –Generally created for drug products that have complicated or detailed...
Read all information on creating instructions for use or IFU for medical devices for the EU & US to comply with (EU) 2017/745 and FDA requirements here. Call us now: +1 786 3297111
E-IFU is eligible for medical device intended for use by professional users only. Paper-form IFU is required and additional electronic IFU is optional for home use devices.
This detailed guide gives you a step-by-step breakdown of everything you need to know when creating IFU for medical devices and in-vitro devices – covering both the U.S and European markets. By reading this guide, you’ll gain clarity on: IFU requirements on medical devices and in-vitro devices in Europe and the U.S
Instructions for Use (IFU) should include a detailed description of your device–including identifying the differences between your medical device and competitor products or previous versions of your own device.
Nov 9, 2021 · Medical devices can be complicated to operate, so pharmaceutical manufacturers have a legal duty to write up easy-to-understand instructions for use (IFU) on any medical devices put out on the market.
Mar 28, 2023 · Medications and medical devices prescribed to patients for at-home use typically include instructions for use (IFU), or directions for proper usage. According to the Food and Drug Administration (FDA), IFUs are critical "to help ensure that patients receive clear, concise information that is easily understood for the safe and effective use" of ...
