LRQA guide on how to classify a medical device

How to classify your Medical DeviceAn important first step for manufacturers in getting their medical device into the European market, is classifying their medical device.

Determining the product classification is important because it determines the product conformity route manufacturers need to take to achieve product approval before you can launch your product into the European market.

Classifying your product and determining the related product conformity route will also help you work out what is required during the product development process as well as establish the costs involved in preparing your product for market.

The classification rules shown in this download will help manufacturers determine which classification applies to their medical device.

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