We offer you in this package the elements that will help you to create your Instruction for Use (IFU) compliant with EU MDR 2017/745. Instruction for use depends on the product. An instruction for use for Wheelchair is not the same as one for a pacemaker or software. So to help you we have developed 2 documents.
- IFU Checklist
- Design Models (Adobe InDesign Models)
IFU Checklist
The first document is the IFU checklist. We have extracted from the EU MDR 2017/745 the requirements listed in Annex I for Instruction For Use.
This checklist is a document that can be included in your quality management system to prove that you have verified all the elements of the EU MDR are available.
The checklist is provided in a Microsoft Excel Format.
Model Adobe InDesign Format
To help you get the final format of the document that you can provide to your customers, here is a model for the Basic Instruction for use document.
This is provided in an Adobe InDesign Format. If you don’t have Adobe InDesign you will not be able to read it.
Basic Model
3-fold Blue Model
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