Active implantable medical devices

constituting medical devices, including any equipment the functioning of which depends on an energy source other than energy generated directly by the human body or by the force of gravity. They are intended to enter, in whole or in part, by surgical or other medical procedure, into the human body or, by medical procedure, into the natural opening of the body, and are intended to remain after surgery in the human body or in the natural opening of the body (Art. Article 2(1)(1) of the Medical Devices Act).