Invasive device

Several MDR classification rules deal with invasive devices, and the class depends on how the device enters the body and for how long. A device entering through a body orifice is classified differently from a surgically invasive one.

‘invasive device’ means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;

EU MDR, Article 2(6)