EU Medical Device Classification Form

Why this Medical Device Classification form?

The EU Medical Device Classification Form is available to help you understand more easily the different rules that exist.

All the rules are placed on a visual format and in front of each of them the rule is clearly defined. The goal is to make your classification easier and without the pain to try to interpret the different definitions.

To help you archive it electronically, we also included electronic boxes so you don’t need to print it and fill it manually. You can do everything on your computer. Even sign it.

Free PDF EU Medical Device Classification Form

This form is composed of 2 parts.

First part, is a form to fill to summaries your project. It includes all the necessary detail of your product so we can have a better understanding of it’s intended use and which category it belongs to.

The second part is listing all the rules and helps you to find which one applies to your product. You can tick the boxes that you consider applicable to your product.

If many rules are applicable you’ll have then to choose the one with the highest classification

When you are done, you can sign the form and archive it on your desktop. You will have to fill a form for each product. At the end, this will help you to prove why you choose this class and to which rule this is applicable.

Download the EU Medical Device Classification Form: Link