Active device

Being active changes how a device is classified under EU MDR Annex VIII, where several rules apply only to active devices. Software always counts as active, while tubing or leads that only pass energy or substances between an active device and the patient without significant change do not.

‘active device’ means 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;

EU MDR, Article 2(4)