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 a device which produces penetration other than through a body orifice.
The term surgical operation used in this definition includes all clinical interventional procedures in which a device is placed into the body through the surface of the body. A surgically invasive device always implies that it enters through an artificially created opening. This can be a large opening, such as a surgical incision, or it can be a pinprick opening made by a needle. Therefore surgical gloves and needles used with syringes are surgically invasive.
In this context the following should be noted:
- a surgically created stoma used in urostomy, colostomy and ileostomy or permanent tracheostomy is considered to be a body orifice; therefore devices introduced into such a stoma are not surgically invasive.
- in contrast, a surgically created opening to allow access to the circulatory system should not be considered to be a body orifice. Devices introduced into such an opening are surgically invasive.
The concept of surgically invasive should be understood to cover also liquids that are in invasive contact with organs, tissues or other parts of the body if the access for such liquids is through a surgically created opening.
For a device that administers a substance, such a substance must be assessed in its own right (e.g. substances administered by a jet injector).
[Definition of term as defined in MDCG 2021-24 No. 3.1.4]