Medical Devices Directive Classification Guide

Medical devices fall into one of four (Class I, Class IIa, Class IIb and Class III) categories depending on the level of risk.

The category is determined by factors such as the length of time the device will be in use, whether the device is implantable, invasive or active, and whether it contains any medical substances. This classification guide will help you to decide which category your product falls into, and is based on the rules in Annex IX of the directive. The download includes the Commission guidance documents on the classification of devices and software. 


Please note:

  • Once you purchase this product, you will receive two emails, the second one containing a link to download the product. The download link will only remain active for 3 days so please make sure you download and save to your computer before this time.
  • The download is a compressed ZIP format and you will need to 'unzip' the file to see the Word and PDF documents contained.
  • VAT will be added at the checkout.
  • All rights reserved. No part of this document is to be re-sold, reproduced or transmitted in any form or by any means, electronic or mechanical, without prior written consent from Conformance Limited. 

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