MDR 2017/745 Technical Documentation Template + Checklist

47,00

To register a Medical Device in the EU Market, the Medical Device manufacturer should create a Technical Documentation for its product. This EU MDR technical Documentation template will provide you all the necessary information that you need to gather.

Included to it is a Checklist that will help you track if you have all the documents available.

This technical documentation template conforms to EU MDR 2017/745 Annex II and Annex III requirements.

Category:

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.

Technical File Template MDR 2017/745 Sample

BONUS

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

Part 1

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.

Part 2

This is matching with the requirements of Annex III of the MDR 2017/745.

It list the requirements for Post-marketing Surveillance.

Appendices

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.

After purchasing this product you will receive a Word document that is editable.
If you have any question, don't hesitate to contact us.

Reviews

There are no reviews yet.

Only logged in customers who have purchased this product may leave a review.