Instructions for use (IFUs) are part of the labeling documentation for medical devices and, as such, are subject to MDR regulatory requirements.
Instructions for use are not required for Class I and Class IIa devices if such devices can be used safely without any such instructions and unless otherwise specified in the MDR. Still, all other devices do need to have their own IFUs.
Understanding where each piece of information in the IFUs comes from is not an easy task and newbies to the world of medical devices would benefit from learning the intricacies of this document before working on any other related documentation.
Also, as a medical device professional, you may even need to provide some of the content in the IFUs for their final version: such as ‘possible adverse events’ or ‘cleaning instructions’. Thus, you may also benefit from the writing recommendations targeting IFUs.
Finally, IFUs are subject to predefined review cycles and depend on several other input documents.
This workshop will give you profound insights into the regulatory requirements for IFUs, best practice recommendations on how to draft IFUs, and insights into common pitfalls and tips on how to avoid them.