LRQA guide on how to classify an in vitro diagnostic device (IVD)

An important first step for manufacturers in getting their in vitro diagnostic device (IVD) into the European market, is classifying their IVD.

Determining the product classification is important because it determines which route within the product conformity procedure manufacturers need to take to achieve product approval before they can launch their product into the European market. Classifying their product and determining the related product conformity route will also help manufacturers work out what is required during the product development process as well as establish the costs involved in preparing their product for market. 

The classification rules shown below will help manufacturers determine which classification applies to their in vitro diagnostic device (IVD).

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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