Case: Classification of medical devices

If your products are within the scope of the Medical Devices Directive (MDD, Directive 93/42/EC), you have to find out which type of the EC Declaration of Conformity is applicable to your product. The Directive sets different classes of products. To determine which class is applicable to you product, Annex IX to the Directive defines rules to classify medical devices. However, finding out the relevant rule for your product, may be quite difficult

Classify your product yourself

The downloadable document provides a flowchart that may help you to classify your product. By answering the question (yes or no), you’ll find out which rule is applicable. After you determined the relevant rule, you can look up the rule (and the classification) in Annex IX to the Directive. A link to the full text of the directive is provided in the external links. If several rules apply to the same device, based on the performance specified for the device, the strictest rules resulting in the higher classification shall apply.

You can find a step by step implementation plan on CE-marking for medical devices in the related document.