This template for your technical documentation is compatible to the requirements of the new MDR 2017/745.
All the requirements listed on the MDR are listed and some guidance are provided to help you pass your certification audit.
This doesn’t contain the different templates of GSPR, PMS, PSUR…
It shows you the structure of all the elements that you should provide. This structure is now mandatory with the new MDR 2017/745 to help the Notified Body provide a clear review.
After Download this product is not subject for reimbursement.
As a complement to the Technical Documentation template, I add to it the Checklist that will help you to audit your situation for the development of your technical file. This is a document that contains all the topics related to the technical documentation and will help you to organize yourself when you will have to put in place an action plan.
Technical File Template Structure
All the general elements required by Annex II of the MDR 2017/745. Additionally, some guide is provided on what you should provide on different sections.
This is matching with the requirements of Annex III of the MDR 2017/745.
It list the requirements for Post-marketing Surveillance.
On the last part of the document, there is a list of suggested appendices. You can also include more if you prefer to reference some of your information from an external document. This document can be then provided in the appendix for a better review of the file.