An invasive device is a device that penetrates, wholly or in part, into the body, either through the skin or through a body orifice. According to the MDR, a body orifice is defined as a natural orifice in the body, as well as the external surface of the eyeball or a permanent artificial opening, such as a stoma.
Invasive devices are defined by the legislator in the MDR in Chapter 1, Article 2, Paragraph 6.
A surgical scalpel that enters the body through the skin, or a catheter that is inserted into the body through a body orifice, is considered to be an invasive device, for example.
