Helping you navigate the world of medical device regulation

A digital tool to make it easier to understand how medical device regulations apply to your product

We have published this tool earlier than planned due to COVID-19, so that innovators can easily navigate the EU medical device regulations. You should expect to see new features and improvements as we continue with the ongoing development of this site.

By clicking "Get Started" you agree to the Terms and Conditions, Privacy Policy, Research Policy and Consent and Cookie Policy
Step 1

Device description

Online support for writing your device description.

Step 2

Medical device

Answer yes or no questions to find out if your product is a medical device according to the EU MDR / IVDR.

Step 3

Classification

Answer yes or no questions to find out what the anticipated classification is according to the EU MDR / IVDR.

Step 4

Result

Receive the anticipated classification of your device. The result will support your conversation with a regulatory expert, notifying body and competent authority.

Before you start

This tool is aimed at people working in the area of medical devices.

You should have a product or idea you are developing and approximately 20 minutes to complete the questions in this tool (times may vary depending on the answers given).

Whilst every effort is made to ensure that the advice provided is comprehensive and as up to date as possible, it is only of a general nature and should not be used as a substitute for consultation with legal and regulatory professionals.