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 it.

Determining the product classification is important, because it determines the product conformity route that manufacturers need to take in order 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 the market. 

The classification rules shown below will help you determine which classification applies to your 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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Image - How to classify your In Vitro Diagnostic Device