€999
An essential IFU medical devices template designed for all manufacturers and importers who trade medical devices within the EU to be able to sell medical devices within the EU, and decrease liability.
Do you want to import, trade and/or sell your medical devices on the European market with ease? Do you want to do this according to the legal requirements to avoid problems at customs or to decrease liability?
We have developed a IFU Medical Device template to make it happen. A lot quicker and easier than you ever imagined.
The IFU medical devices template is an MS Word document that contains all mandatory elements to create your own Information For Use (IFU) for medical devices.
You can use the template to create an IFU that complies with the CE marking requirements, the Medical Device Regulation (EU) 2017/745, the EN IEC/IEEE 82079-1 standard for Instructions for Use, and the ANSI Z535.6 for Safety Messages.
All our templates have a 14-day, no-reason-required guarantee. So if you are not satisfied, for any reason, just let us know and we’ll refund your money.
As we truly believe our IFU template will help you create better documentation, we don’t think it’ll come to that.
But as soon as you have any doubts whether our user manual template is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!
We have provided everything you’ll ever need to create instructions for use that are compliant to regulatory requirements. Trade with ease and worry no more about impending liabilities.
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 or 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 (EU) 2017/745 for Medical Devices gives requirements on the content of the Information for Use, called the Essential Requirements.
The IFU Medical Device 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 compliant instructions.
Besides CE marking directives and regulations, other directives/regulations might apply to your product, such as the WEEE, REACH, packaging or battery directive. These also give requirements on the information that needs to be provided with the product, mostly related to safe disposal.
The IFU Medical Device Template contains ready-to-use texts to comply with these requirements.
The IEC/IEEE 82079-1 Preparation of Instructions for Use is an international standard that provides both general principles and detailed requirements for the design and formulation of all types of Information for Use.
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 IFU Medical Devices 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, and 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.
€999
Lothar Naujokat
Director, HANNETS
“The Instruction Manual 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!”
Philip Olsson
CEO, ISOVOX Sweden
“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.”
Keen to find out how we can help you? Contact us now!
