AstraClass

AstraClass is a very convenient classification tool for medical devices. Step-by-step, it will guide you through several questions. At the end of which, you will learn about the classification of your device, as well as the corresponding rule. The rules are the same as those found in MDR (EU) 2017/745 and IVDR (EU) 2017/746. Additionally, we included guidance wherever terms might not be clear. After using the tool, you can use the risk class as well as the MDR/IVDR rule in your Technical Documentation as a basis for your conformity assessment.

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