Active (medical) device

Any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device.

Note 1 to entry: this term is synonym of Digital Medical Device for the purposes of the DiCE project.

source: Regulation (EU) 2017/745 on medical devices (MDR)