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MDR CLASSIFICATION GUIDE

A guide on how to classify your medical device.

An important first step for manufacturers in getting their medical device into the European market is classifying it.

Identifying 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 in this guide will help you determine which classification applies to your medical device.

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