Creating instructions for use (IFU) for medical devices and in vitro diagnostic products requires you to take quite a lot of responsibility. In fact, you need to combine your techcomm skills with project management, administrative and legal skills. Luckily, what needs to be included in the instructions for use for medical devices has been determined in relevant legislation.
If there is any industry in which it is important to make sure that users can use devices safely, effectively and efficiently, it is the medical industry. And let us not forget the importance of decreasing your liability by means of adequate instructions for use.
If you want to create a medical device user manual you need to be aware of both the content to include and the process to follow.
In this guide, everything is shown what is needed to know when creating IFU for medical devices. It is not only shown how to create IFU for the US market, but also for the European market. The requirements for both markets for medical devices as well as for in vitro medical devices are shown.
This article provides sufficient medical device instructions for use guidelines and that it gives deep insight into relevant regulation on what everyone have to include in the IFU, in order to meet relevant EU regulations and/or the Code of Federal Regulations (CFR) in the USA.
Understanding and applying the requirements will help to pass Notified Body conformity assessment (in Europe) and FDA approval in the USA.
For the IFU guidelines for the USA click here
; for IFU requirements of in vitro devices in the USA click here
For the IFU requirements on medical devices in Europe click here
and for creating the IFU for in vitro devices for Europe click here