             
 |
|
Rules - MDD ClassificationSince the general Directive concerning medical devices covers a very wide spectrum of products, it has not been considered appropriate to use the same conformity assessment procedure for all medical devices.The Directive therefore divides the medical devices into four different classes (I, IIa, IIb and III). In addition, class I is subdivided into devices which are sold in a sterile condition and devices which are sold with a measuring function. The classification reflects the risks involved in the use of the product, the vulnerability of the parts of the body on which the devices are to be applied and the duration of use. The highest risk class (III) thus includes eg products which come into contact with the central nervous system, the heart or the central circulatory system as well as medical devices incorporating medicines. The classification thus ensures that the control is reasonably proportional to the risk involved in the use of the product. Back to index |
|