Which class is your in-vitro diagnostic medical device?

Your product is an in-vitro medical device. What is the classification?

In-vitro diagnostic medical devices are divided into four classes: A, B, C and D. This classification is based on risk: the higher the risk to the patient if the medical device fails, the higher the class. The higher the device's class, the more stringent the scrutiny process will be.

To determine the risk of the use of a device and therefore which class is applicable, the intended medical purpose is used. Based on the intended purpose, the applicable MDR classification rules are determined. In total there are 7 classification rules, which determine the risk class. The quick scan classification provides an initial estimate of the correct class.

Not sure if your device is a medical device? Take a look at the Quick scan 'Medical Device?' and the Laws & Rules page.

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