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)
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.