The definitive guide to IFU for Medical Devices

When it comes to finding information about commercialising your medical devices, there’s a lot of information out there – but it can be a confusing space to navigate. To make your experience simpler, we’ve collaborated with the people at INSTRKTIV to share the definitive guide to IFU for medical devices – ensuring devices can be used safely and effectively in an industry where attention to detail is essential.

View the definitive guide

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
• Relevant regulation on what should be included in your IFU to meet EU regulations and/or the Code of Federal Regulations (CFR) in the U.S
• Understanding and applying the requirements to pass the Notified Body conformity assessment (in Europe) and FDA approval in the U.S.
• General labelling requirements – including giving a clear description of intended uses, directions for use, date formatting, and labelling guidance