Glossary

Surgically invasive device [MDR]

MDR

‘Surgically invasive device’ means:

(a) an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; and

(b) a device which produces penetration other than through a body orifice.

 

[Definition according to (EU) 2017/745 Annex VIII Chapter I No. 2.2]