Simplify the classification of your medical devices with our new widget!

In the field of medical devices, regulatory classification is a crucial step in ensuring compliance with current standards and ensuring patient safety. Whether you are a manufacturer, distributor, or consultant, correctly identifying the class of a device can be complex and time-consuming.

To assist you in this process, we have designed an intuitive and efficient widget that allows you to quickly determine the regulatory class of your devices, according to the criteria defined by international regulations, notably the Regulation (EU) 2017/745 (MDR).

Why should you use our widget?

1-Save valuable time Classification may require an in-depth analysis of MDR rules. Our widget guides you through a few simple steps, allowing you to save considerable time.

2-Reliable and compliant results Based on MDR rules 1 to 22, the widget helps you identify the appropriate class for your device (I, IIa, IIb, or III), while respecting current regulatory requirements.

3-An accessible and easy-to-use tool No need to be a regulatory expert: the widget has been designed to be clear, intuitive, and accessible to all professionals in the field.

How does it work?

The widget works by guiding you through a series of questions based on the characteristics of your medical device. You will be asked to respond to criteria such as:

• The type of device (diagnostic, therapeutic, etc.)
• Its level of invasiveness
• The duration of contact with the human body
• The risk associated with its use
• And much more!

At the end of the process, the widget indicates the estimated regulatory class as well as the MDR rules justifying this classification, particularly those involving the highest class for your device.

⚠️ Important: this tool is a valuable aid, but it does not replace a comprehensive analysis. It is essential to review all MDR rules and confirm their applicability to your product to ensure total compliance.

Try it now

👉 Test our widget here: Link to the widget

Any doubts or need for personalized support? Contact us, we are here to help.