The function of information for use (ifu) is to explain to the user how a medical device can be used safely, efficiently and effectively. The information for use informs the user about risks that still persist, despite the adoption of measures for inherent safe design, safeguarding and complementary protection. Failure to warn the user properly can make the manufacturer liable in case of any accidents. That’s why the duty to warn/provide ifu with the products is regulated and often mandatory. The IFU Medical Device Template is a MS Word file that contains all mandatory elements, as required by CE marking and other relevant European product safety directives, to create your own compliant ifu for the EU market.
The Regulation on Medical Devices gives requirements on the content of the instructions for use, called the Essential Requirements. The Information for Use Template contains all these mandatory elements that are placed in the right position, so you know exactly what to add and where to add it in order to create a compliant ifu. Besides CE marking directives, other directives might apply to your product, such as the WEEE, REACH, packaging or battery directive. These directives also give requirements on the information that needs to be provided with the product, mostly related to safe disposal. The IFU Medical Devices Template contains ready-to-use texts to comply with these requirements.
“The IFU Template helped our engineers to create the user manuals for our latest product. It contains all the information you need to create your own compliant manuals, so you don’t have to outsource this! It is such a time saver!”
“The factory manuals always need to be redone. This was a daunting task for us: we never knew where to begin and at the end we were not sure if the manual did comply. The User Manual Template provides us all relevant information so we can create compliant instructions and decrease our liability.”
The EN IEC 82079-1:2012 Preparation of instructions for use is an international standard that provides both general principles and detailed guidelines for the design and formulation of all types of user instructions. The standard has been harmonised by the EU, which means that by applying the standard you create the highest level of presumption of conformity with the Essential Requirements of the Directives. The IFU Medical Devices Template contains all elements as provided by the 82079 that can be easily adjusted to your own needs. The table of contents of the User Manual Template is based on the content requirements as given by this internationally recognised standard.
The ISO 3864 standard specifies international standards for safety symbols, including the formatting of the DANGER, WARNING, CAUTION safety symbol panels. The ANSI Z535.6 also describes the formatting of these, but also gives requirements on when to use which warning level, where to place safety messages throughout the manual and how to use words like shall, could and may. The IFU Medical Devices Template has adopted the requirements from this standard, so you will be able to create compliant safety instructions.