Knowing the correct class for your Medical Device is critical. The class has an number of regulatory, clinical, quality and risk implications. If completed incorrectly the Notified Body may decide your product should go up a class, which can cause significant delays and cost. 

In the two videos below Educo Life Sciences trainer Richard Young examines the classification and the rules you must follow.

Classification overview and Class 1, 2a, 2b and 3 

Richard explains how medical device classification works and then discusses each class in more detail. Class 1, 2a, 2b and 3. He provides examples of each class and analyses the regulatory and risk implications for each.

 

Classification rules (All 22)

In order to determine what class your device is, you must follow the classification rules outlined in the Medical Devices Regulation (MDR). There are 22 rules you must read and follow. Richard analyses each rule providing a brief interpretation. He also provides examples of devices for each rule.

 

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