LRQA guide on how to classify a medical device

An 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 below will help manufacturers determine which classification applies to their medical device.

As a leading Notified Body with more than 20 years’ experience in the medical arena, LRQA can help you verify the requirements relating to your products, and work with you to determine the best options for you.

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